March 2026 FDA Recall Tramadol Hydrochloride by Amneal Pharmaceuticals, Llc
D-0408-2026 - Failed Impurities/Degradation Specifications

This Class II drug recall was voluntarily initiated by Amneal Pharmaceuticals, Llc on March 19, 2026 for the product Tramadol Hydrochloride. The FDA reported the reason for recall as failed impurities/degradation specifications. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0408-2026

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).
Initiated
03-19-2026
Reported
04-08-2026
Quantity
29,542 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98623
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Amneal Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide within the USA
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

Lot# : AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.

Affected Packages Involved in this Recall

60219-2348-4 Tramadol Hydrochloride
60219-2348-1 Tramadol Hydrochloride
60219-2348-5 Tramadol Hydrochloride
60219-2348-7 Tramadol Hydrochloride