Enforcement radar
Real enforcement — not just rule changes
FDA & FTC enforcement hitting GLP-1 and compounded products — recalls, warning letters, and FTC actions, each labeled by type. If the pharmacy or outsourcing facility your med spa sources from lands here, that’s a patient-safety and liability problem today — not a rule that might change. Monitoring, not legal advice.
Monitored daily · sources last scanned Nov 14, 2026newest action Oct 21, 2026
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- CAUTIONFDA ACTIONOct 21, 2026
FDA recall (Class II): Tirzepatide/Niacinamide 2mL vial (40 Mg per Vial) Inj 20mg/2mg/mL, Rx Only, Houston Rx LLC, 15430 Vantage Parkway E Ste…
FDA Class II recall of Tirzepatide/Niacinamide due to sterility concerns.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CRITICALFDA ACTIONOct 14, 2026
FDA recall (Class II): Semaglutide 3 MG/ML Injectable, 8 x 0.1 mL syringes, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, Sc 29936
FDA recalls compounded semaglutide for sterility concerns; initiated Sept 10, 20
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CRITICALFDA ACTIONOct 14, 2026
FDA recall (Class II): Tirzepatide/CYANOCOBALAMIN 26/2 MG/ML Injectable, Packaged in single-use dosage syringes, total mL dispensed based on d…
FDA recalls tirzepatide/cyanocobalamin due to sterility issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONOct 14, 2026
FDA recall (Class II): Semaglutide/CYANOCOBALAMIN 9/2 MG/ML Injectable, Packaged in single-use dosage syringes, total mL dispensed based on DO…
FDA recalls compounded semaglutide for sterility concerns; initiated Sept 10, 20
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONOct 14, 2026
FDA recall (Class II): Tirzepatide/CYANOCOBALAMIN 76/2 MG/ML Injectable, Packaged in single-use dosage syringes, total mL dispensed based on d…
FDA recalls Tirzepatide/Cyanocobalamin due to sterility concerns.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONOct 14, 2026
FDA recall (Class II): Tirzepatide 26 MG/ML Injectable, Packaged in single-use dosage syringes, total mL dispensed based on dosage per specifi…
FDA issues Class II recall for compounded tirzepatide; effective Sept 10, 2026.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONOct 14, 2026
FDA recall (Class II): Tirzepatide/CYANOCOBALAMIN 64/2 MG/ML Injectable, Packaged in single-use dosage syringes, total mL dispensed based on d…
FDA recalls injectable tirzepatide/cyanocobalamin due to sterility issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONOct 14, 2026
FDA recall (Class II): Tirzepatide/CYANOCOBALAMIN 85/2 MG/ML Injectable, Packaged in single-use dosage syringes, total mL dispensed based on d…
FDA recall of compounded Tirzepatide due to sterility issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CAUTIONFDA ACTIONOct 14, 2026
FDA recall (Class II): Tirzepatide Injection, 18mg/mL, 4 mL Sterile Multi-Dose Vial, Rx only, Apothecary Pharma, LLC, 1913 Evans Road, Cary, N…
Class II recall of Tirzepatide Injection over sterility concerns; initiated Sept
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONOct 14, 2026
FDA recall (Class II): Semaglutide/CYANOCOBALAMIN 3/2 MG/ML Injectable, Packaged in single-use dosage syringes, total mL dispensed based on DO…
FDA recalls compounded semaglutide over sterility concerns; effective Sept 10, 2
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CAUTIONWARNING LETTEROct 1, 2026
FDA Warning Letter: Zhejiang Gaorong Cosmetic Co., Ltd (Drugs)
Zhejiang Gaorong Cosmetic Co., Ltd received an FDA Warning Letter on Oct 1, 2026
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CAUTIONWARNING LETTEROct 1, 2026
FDA Warning Letter: RoyceDerm, LLC (Drugs)
RoyceDerm, LLC received an FDA Warning Letter for drug-related issues; verify de
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CRITICALWARNING LETTERFDA: OAISep 18, 2026
FDA Warning Letter: Empower Clinic Services, LLC (Drugs)
FDA cites Empower Clinic Services for CGMP violations; effective Sept 18, 2026.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CRITICALDEVICE RECALLSep 16, 2026
FDA device recall (Class II): Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device that delivers pulsed laser energy a…
FDA recalls DermaV Laser System; check for safety compliance.
What to do — members only.Become a member →FDA Device Recallprimary source ↗ - CRITICALWARNING LETTERFDA: OAISep 14, 2026
FDA Warning Letter: Sca Pharmaceuticals, Inc. (Drugs)
SCA Pharmaceuticals received an FDA Warning Letter; verify your supply sources.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CAUTIONWARNING LETTERFDA: VAIAug 25, 2026
FDA Warning Letter: Advance-Esthetic LLC (Devices)
FDA says Zemits CrystalFrax Pro, Abigon Pro and Bionexis Lite Pro RF and light body-contouring devices lack required FDA approval or clearance.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CAUTIONWARNING LETTERAug 24, 2026
FDA Warning Letter: Peptide Partners, LLC (Drugs)
FDA says Peptide Partners' "research use only" GLP-1s and other injectable peptides are unapproved drugs. Health claims on its own product pages were FDA's evidence that they were intended for human use.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CAUTIONWARNING LETTERAug 24, 2026
FDA Warning Letter: Royal Peptides LLC (Drugs)
FDA says Royal Peptides' "research use only" GLP-1s and other peptides are unapproved drugs. Its weight-loss claims, and the bacteriostatic water, "peptide guide" and "peptide calculator" sold alongside them, were FDA's evidence they were meant for injection in people.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CAUTIONWARNING LETTERAug 24, 2026
FDA Warning Letter: Peak Performance Peptides (Drugs)
FDA says Peak Performance Peptides' "research use only" semaglutide, retatrutide and other peptides, and the BAC water sold with them, are unapproved.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CRITICALFDA ACTIONAug 19, 2026
Source qualification pending
Consequential guidance is withheld while the exact primary source, scope or named-entity binding is reviewed. This is an unresolved qualification gap, not a finding that the underlying report is false.
FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 19, 2026
FDA recall (Class II): Semaglutide 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injectio…
FDA recalls semaglutide 7.5mg due to particulate contamination.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 19, 2026
FDA recall (Class II): Semaglutide 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, Apollo care, 3801 …
Recall of contaminated semaglutide vials.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 19, 2026
FDA recall (Class II): Semaglutide 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, Apollo care, 380…
FDA recalls semaglutide 12.5mg due to contamination risks.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 19, 2026
FDA recall (Class II): Semaglutide 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injecti…
Apollo Care recalls semaglutide for harmful particulate matter.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 19, 2026
FDA recall (Class II): Semaglutide 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection On…
FDA recalls semaglutide due to contamination risks.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 19, 2026
FDA recall (Class II): Semaglutide 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection On…
Important recall: Check your inventory for affected semaglutide vials.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 19, 2026
FDA recall (Class II): Semaglutide 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, Apollo care, 380…
FDA recalls semaglutide from Apollo Care due to contamination.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 19, 2026
FDA recall (Class II): Semaglutide 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, Apollo care, 380…
FDA recalls semaglutide vials due to contamination concerns.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 19, 2026
FDA recall (Class II): Semaglutide 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, Apollo care, …
FDA recalls semaglutide due to contamination risks.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 19, 2026
FDA recall (Class II): Semaglutide 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Onl…
Recall of compounded semaglutide due to contamination reported.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CRITICALWARNING LETTERFDA: OAIJul 8, 2026
FDA Warning Letter: Spa De Soleil, Inc. (Drugs)
Water Spa De Soleil uses to make over-the-counter topical products failed testing 51 times from 2024 to 2025. FDA had cited similar problems in 2021.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CAUTIONWARNING LETTERJun 23, 2026
FDA Warning Letter: ketaminelab.org (Drugs)
FDA says buyketaminepowderonline.com (formerly ketaminelab.org) sells unapproved, misbranded ketamine powder online.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CAUTIONWARNING LETTERJun 17, 2026
Source qualification pending
Consequential guidance is withheld while the exact primary source, scope or named-entity binding is reviewed. This is an unresolved qualification gap, not a finding that the underlying report is false.
FDA Warning Letterprimary source ↗ - CAUTIONWARNING LETTERJun 17, 2026
FDA Warning Letter: Wholesale Peptide (Drugs)
FDA says Wholesale Peptide's injectable "Prostamax" and gonadorelin are unapproved new drugs.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CAUTIONWARNING LETTERJun 17, 2026
Source qualification pending
Consequential guidance is withheld while the exact primary source, scope or named-entity binding is reviewed. This is an unresolved qualification gap, not a finding that the underlying report is false.
FDA Warning Letterprimary source ↗ - CAUTIONWARNING LETTERJun 17, 2026
Source qualification pending
Consequential guidance is withheld while the exact primary source, scope or named-entity binding is reviewed. This is an unresolved qualification gap, not a finding that the underlying report is false.
FDA Warning Letterprimary source ↗ - CAUTIONWARNING LETTERJun 17, 2026
FDA Warning Letter: Herbal Dermals LLC Fz (Drugs)
FDA says Gotucream, sold online as a balanitis treatment cream, is an unapproved new drug.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CAUTIONFTC ACTIONJun 12, 2026
FTC Files Contempt Motion Against Amare Global and Three Individuals Over Unsubstantiated Health Claims
FTC targets deceptive health claims affecting aesthetic practices.
What to do — members only.Become a member →FTC Enforcementprimary source ↗ - CRITICALFDA ACTIONMay 27, 2026
Source qualification pending
Consequential guidance is withheld while the exact primary source, scope or named-entity binding is reviewed. This is an unresolved qualification gap, not a finding that the underlying report is false.
FDA Enforcementprimary source ↗ - CRITICALWARNING LETTERFDA: OAIMay 12, 2026
FDA Warning Letter: Fresenius Kabi Compounding, LLC (Drugs)
FDA Warning Letter issued to Fresenius Kabi Compounding, LLC.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CRITICALWARNING LETTERFDA: OAIApr 22, 2026
FDA Warning Letter: Active Cosmetics Manufacturing Inc (Drugs)
FDA cites Active Cosmetics Manufacturing for releasing OTC topical drugs after failed microbial tests, including S. aureus.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - MONITORFDA ACTIONApr 22, 2026
FDA recall (Class II): Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials, Rx only, Northwest Compounders, Bea…
Historical FDA recall D-0471-2026 covers Northwest Compounders semaglutide-glycine-cyanocobalamin injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL vials; Lot Number 01-27-2026@14S.5.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CAUTIONWARNING LETTERFDA: OAIApr 20, 2026
FDA Warning Letter: Foshan Miwei Cosmetics Co., Ltd. (Drugs)
FDA cites Foshan Miwei Cosmetics for releasing OTC drug products without testing active-ingredient strength or microbes.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CAUTIONWARNING LETTERApr 2, 2026
FDA Warning Letter: Purolea Cosmetics Lab (Drugs)
FDA cites Purolea Cosmetics Lab for insects and filth in its plant and for untested homeopathic drug products.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CAUTIONWARNING LETTERApr 1, 2026
FDA Warning Letter: Pure Indulgence Aesthetics (Drugs)
FDA says a Texas med spa administered far more Botox than it bought from AbbVie, and so had sourced toxin from unauthorized suppliers.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CAUTIONWARNING LETTERMar 31, 2026
FDA Warning Letter: Mile High Compounds (Drugs)
FDA says the "research-only" semaglutide, tirzepatide and retatrutide sold by Mile High Compounds are unapproved injectable drugs. The firm's own weight-loss dosing guides, shared through its online forum, were FDA's evidence that the products were meant for people.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CAUTIONWARNING LETTERMar 31, 2026
FDA Warning Letter: Gram Peptides (Drugs)
FDA says GRAM Peptides' "research use only" retatrutide and tirzepatide, sold with bacteriostatic water, are unapproved drugs.
What to do — members only.Become a member →FDA Warning Letterprimary source ↗ - CAUTIONDEVICE RECALLMar 18, 2026
FDA device recall (Class II): Clarity II Laser System; Model No. 1110200210.
FDA recalls Clarity II Laser System for safety concerns.
What to do — members only.Become a member →FDA Device Recallprimary source ↗ - MONITORFDA ACTIONMar 11, 2026
FDA recall (Class II): Semaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, Ks 66061, …
FDA recalls compounded GLP-1 product over sterility concerns.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CAUTIONFDA ACTIONMar 11, 2026
Source qualification pending
Consequential guidance is withheld while the exact primary source, scope or named-entity binding is reviewed. This is an unresolved qualification gap, not a finding that the underlying report is false.
FDA Enforcementprimary source ↗ - CRITICALFDA ACTIONMar 11, 2026
FDA recall (Class II): Semaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, Ks 66061,…
Historical FDA recall D-0393-2026 covers Nomida semaglutide injection, 2 mg x 5; Lot 240903, exp 9/30/2026.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CAUTIONFDA ACTIONMar 11, 2026
FDA recall (Class II): Tirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, Ks 66061, …
Historical FDA recall D-0395-2026 covers Nomida tirzepatide injection, 15 mg x 4; Lot 240709, exp 7/31/2026.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONMar 11, 2026
FDA recall (Class II): Semaglutide, For Rx compounding use only, packaged in a) 1g, NDC 84385-106-01; b) 5g, NDC 84385-106-02; c) 10g, NDC 843…
Important recall on compounded Semaglutide products affecting med spas.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONMar 11, 2026
FDA recall (Class II): Tirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, Ks 66061, NDC …
FDA recalls Tirzepatide injection over sterility issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORDEVICE RECALLJan 28, 2026
FDA device recall (Class II): Brand Name: Leaseir Product Name: Leaseir Mhr Xcell Model/Catalog Number: Mhr 110-b Software Version: 1.5.0.0 Product D…
Leaseir MHR Xcell laser recalled for safety issues.
What to do — members only.Become a member →FDA Device Recallprimary source ↗ - CRITICALFDA ACTIONJan 7, 2026
FDA recall (Class II): Wegovy (Semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880…
Historical FDA recall D-0244-2026 covers Wegovy 0.5 mg/0.5 mL pens; Lot #: RZFHD52, RZFHW93; Exp Date 10/31/2026.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONJan 7, 2026
FDA recall (Class II): Wegovy (Semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Manufactured by: Novo Nordisk A/S, DK-2880 B…
FDA recalls Wegovy due to safety concerns; med spas must act.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONNov 5, 2025
FDA recall (Class II): Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Je…
FDA recalls Semaglutide injection over sterility issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONNov 5, 2025
FDA recall (Class II): Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 J…
FDA recalls Semaglutide injection due to sterility concerns.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONNov 5, 2025
FDA recall (Class II): Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef…
FDA recalls GLP-1 product; take immediate action.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CAUTIONFDA ACTIONNov 5, 2025
FDA recall (Class II): Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jef…
Historical FDA recall D-0118-2026 covers ProRx semaglutide injection, 2.5 mg/1 mL; Lot Prorx051525-5.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONNov 5, 2025
FDA recall (Class II): Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeff…
FDA recalls GLP-1 injection over sterility concerns.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONNov 5, 2025
FDA recall (Class II): Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 J…
FDA recalls Semaglutide injection due to sterility issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONNov 5, 2025
FDA recall (Class II): Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeff…
Historical FDA recall D-0120-2026 covers ProRx tirzepatide injection, 27 mg/3 mL; Lot PRORX08062025-3.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONOct 15, 2025
FDA recall (Class II): Semaglutide for Injection, a) 20 mg b) 20 mg/mL, 10 mL Multi-Dose Vials, GenoGenix, LLC, 2840 Nw 2nd Ave Ste 204 Boca R…
FDA recalls semaglutide over sterility issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONOct 15, 2025
Source qualification pending
Consequential guidance is withheld while the exact primary source, scope or named-entity binding is reviewed. This is an unresolved qualification gap, not a finding that the underlying report is false.
FDA Enforcementprimary source ↗ - MONITORFDA ACTIONOct 15, 2025
FDA recall (Class II): Tirzepatide, 60mg/10 mL for Injection, 10mL vial lyophilized, all presentations, GenoGenix, LLC, 2840 Nw 2nd Ave Ste 20…
Historical FDA recall D-0092-2026 covers GenoGenix tirzepatide, 60 mg/10 mL lyophilized vials, including the Extension Health and Synergy Wellness presentations named in this record; Lots GG012925-005, GG021125-003, within expiry.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONSep 10, 2025
FDA recall (Class II): Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy
Class II recall of Boothwyn Pharmacy semaglutide injection (subpotent).
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CRITICALFDA ACTIONSep 10, 2025
FDA recall (Class II): Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy
Historical FDA recall D-0606-2025 covers Boothwyn semaglutide injection, 2.5 mg/mL, 2 mL; 03202025@5, 03202025@6, 03202025@7, 03202025@8 BUD 07/18/2025.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONSep 10, 2025
FDA recall (Class II): Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy
Urgent: GLP-1 injection recall for med spas sourcing compounded products.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 13, 2025
FDA recall (Class II): Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Steri…
Important recall for compounded GLP-1 products impacts med spas.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 13, 2025
FDA recall (Class II): Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2…
FDA recalls compounded GLP-1 product due to safety concerns.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 13, 2025
FDA recall (Class II): Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile…
FDA recalls compounded GLP-1 product.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 13, 2025
FDA recall (Class II): Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) s…
Stay informed: GLP-1 injectable recall may affect your practice.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 13, 2025
FDA recall (Class II): Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2…
Important FDA recall for compounded GLP-1 product impacts med spas.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CRITICALFDA ACTIONAug 13, 2025
FDA recall (Class II): Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, …
FDA recall D-0560-2025, initiated July 18, 2025, covered Aequita tirzepatide + niacinamide, 16.6 mg + 1.0 mg/0.5 mL, 3 x 2 mL multidose vials in the historical cohort identified as 'All Lots within expiry'.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 13, 2025
FDA recall (Class II): Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2…
Important recall of GLP-1 compounded product.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 13, 2025
FDA recall (Class II): Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, …
FDA recalls compounded GLP-1 product due to processing controls issue.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 13, 2025
FDA recall (Class II): Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Steri…
Ongoing recall of compounded GLP-1 product.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 13, 2025
FDA recall (Class II): Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Steri…
Alert: GLP-1 product recall due to processing issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 13, 2025
FDA recall (Class II): Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile, 2…
FDA recalls a GLP-1 product; check your supply immediately.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONAug 13, 2025
FDA recall (Class II): Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Sterile,…
FDA recalls compounded GLP-1 product over safety issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CRITICALFDA ACTIONAug 13, 2025
FDA recall (Class II): Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50 units on syringe) subcutaneously, Steri…
FDA recall D-0565-2025, initiated July 18, 2025, covered Aequita semaglutide + cyanocobalamin, 2.67 mg + 0.25 mg/0.5 mL, 2 mL multidose vials in the historical cohort identified as 'All Lots within expiry'.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CRITICALFDA ACTIONJul 2, 2025
FDA recall (Class II): Semaglutide, 2.5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, Co 80…
Historical FDA recall D-0479-2025 covers Thrive semaglutide, 2.5 mg/mL, prefilled syringes; Lot #: H270221, Exp 12/26/2025.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONJul 2, 2025
FDA recall (Class II): Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewo…
FDA recalls Tirzepatide for sterility issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONJul 2, 2025
FDA recall (Class II): Tirzepatide/Cyanocobalamin Injectable, 15mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, S…
Class II recall of Thrive Health tirzepatide/B12 over sterility.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - CRITICALFDA ACTIONJul 2, 2025
FDA recall (Class II): Tirzepatide Injections, 30mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewo…
FDA recalls Tirzepatide injections; action needed.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONJul 2, 2025
FDA recall (Class II): Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Su…
FDA recalls compounded GLP-1 product for sterility issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONJul 2, 2025
FDA recall (Class II): Semaglutide, 5 mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewood, Co 80112
FDA recalls compounded GLP-1 product over sterility issues.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONJul 2, 2025
FDA recall (Class II): Tirzepatide Injections, 10mg/mL, pre-filled syringe, Thrive Health Solutions, 88 Inverness, Cir E, Suite A-204, Englewo…
Class II recall of Thrive Health tirzepatide over sterility concerns.
What to do — members only.Become a member →FDA Enforcementprimary source ↗ - MONITORFDA ACTIONJul 2, 2025
FDA recall (Class II): Tirzepatide/Cyanocobalamin Injectable, 30mg/1mg/mL (15mg/0.5mg/0.5mL), pre-filled syringe, Thrive Health Solutions, 88 …
FDA recalls GLP-1 product due to sterility concerns.
What to do — members only.Become a member →FDA Enforcementprimary source ↗
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