traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Lt
Summary
The FDA issued a Class II for traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufac by Amneal Pharmaceuticals, LLC. Reason: Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability i.
Details
Source
Drug Recall
External ID
D-0408-2026
Action Date
2026-04-08
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
Quantity Affected: 29,542 bottles
Reason for Recall
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).
Distribution
Nationwide within the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-19
Company
Bridgewater, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 53 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Amneal Pharmaceuticals, LLC has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Amneal Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amneal Pharmaceuticals, LLC have FDA actions?
Amneal Pharmaceuticals, LLC has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0408-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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