FDA import refusal: Lidocaine (Anesthetic) (India)
FDA refused entry of lidocaine from India; confirm violation details.
What changed & why it matters
MedSpaRadar recorded an FDA import refusal at the federal level, dated October 21, 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
- October 21, 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.
What to do
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The FDA record
- Firm
- CIMERA CARE PVT LTD
- Origin
- Uttarkand, India
- Product
- Lidocaine (Anesthetic)
- FDA classification
- Human Drugs
- Refused
- Oct 21, 2026
- FDA district
- Division of Southeast Imports
- Firm FEI
- 3031231527
- FDA shipment ID
- AEK-2027330-5/110002/1
Why FDA refused it
Unapproved New Drug505(a), 801(a)(3); UNAPPROVED NEW DRUG
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
FDA charge codes on this record: 75 (Unapproved New Drug). 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-2027330-5/110002/1 (or firm FEI 3031231527), refused Oct 21, 2026.
FDA Import Refusal · FDA Import Refusals database ↗FDA record · CIMERA CARE PVT LTD · Uttarkand · drug product · refused as unapproved new drug
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MedSpaRadar is regulatory monitoring and reference: it summarizes public laws, regulations and agency actions and links each to its source. It is not legal, medical, or compliance advice, and using it creates no attorney-client relationship. A summary can lag its source or leave out detail, and monitoring itself can be interrupted — so an absence of alerts means nothing reached you, not that nothing happened. Read the cited source, check its effective date, and confirm any change to your operations or clinical practice with qualified health-law counsel and your medical director.