FDA import refusal: Lidocaine Hcl (Anesthetic) (India)
FDA refuses entry of Lidocaine HCl from India; stay cautious.
What changed & why it matters
MedSpaRadar recorded an FDA import refusal at the federal level, dated June 29, 2026, in the Aesthetic Injectables category, naming LIDOCAINE.
An import refusal marks a shipment of LIDOCAINE the FDA stopped at the U.S. border as violative — the gray-market corridor a med spa must never source injectables from. Foreign, unapproved, or misbranded product refused at import is exactly what surfaces when a practice buys outside verified US-licensed 503A/503B or FDA-registered channels.
- Type
- FDA Import Refusal
- Jurisdiction
- Federal
- Category
- Aesthetic Injectables
- Substance
- LIDOCAINE
- Recorded
- June 29, 2026
What this means for your practice — the step to take, the deadline to calendar or the supplier detail to check, where the change calls for one — is in the member "what to do" below. This page is the free record of what changed and why it matters.
Firm inspection: Official Action Indicated
This firm’s most recent FDA inspection was classified Official Action Indicated (OAI) — FDA’s most serious outcome, signaling significant violations.
Source: FDA Data Dashboard inspection classifications (most recent, by firm FEI).
What to do
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The FDA record
- Firm
- Mahendra Chemicals
- Origin
- Ahmedabad, India
- Product
- Lidocaine Hcl (Anesthetic)
- FDA classification
- Human Drugs
- Refused
- Jun 29, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3003802404
- FDA shipment ID
- AEK-0568521-8/10002/1
Why FDA refused it
Adulteration501(a)(2)(B), 801(a)(3); ADULTERATION
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
FDA charge codes on this record: 27 (Adulteration). Definitions via the FDA Refusal Charges Reference.
Verify at FDA
FDA doesn’t publish a page per refusal. Open the FDA Import Refusals database and search by shipment ID AEK-0568521-8/10002/1 (or firm FEI 3003802404), refused Jun 29, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · Mahendra Chemicals · Ahmedabad · drug product · refused as adulteration
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