traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles

Amneal Pharmaceuticals, LLC has recalled traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on April 8, 2026 and was initiated on March 19, 2026. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, with approximately 29,542 bottles affected. The company behind the recall is Amneal Pharmaceuticals, LLC, based in Bridgewater, NJ. The FDA describes the product as: “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.”

Why was traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles recalled?

According to the FDA, the stated reason for the recall is: “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).” In plain terms, this recall relates to a chemical impurity.

This recall involves an unwanted chemical detected in the medicine — often a nitrosamine impurity, which regulators limit because long-term exposure above set levels may increase health risks. Regulators recall affected batches as a precaution. Health authorities generally advise talking to a doctor or pharmacist before stopping a prescribed medicine.

What should you do?

If you think you may have bought traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, compare it against the product description and identifying codes (Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Amneal Pharmaceuticals, LLC or your local health authority.

About this recall

This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.