⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Amneal Pharmaceuticals, LLC: traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220

DrugsSource: FDA (drug) · Date: 2026-04-08

Read the official notice at FDA (drug) →

Share on XFacebookRedditEmail

Get alerts for Amneal Pharmaceuticals

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Amneal Pharmaceuticals, LLC
Product
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141, NDC 60219-2348-5.
Reason / hazard
Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide within the USA
Recall initiated
2026-03-19
Code info
Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
Product quantity
29,542 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Bridgewater
State
NJ
Country
United States
Event id
98623
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.