Amneal Pharmaceuticals is recalling 29,542 bottles of TRAMADOL HYDROCHLORIDE tablets distributed nationwide in the United States. The recall cites a failed impurity specification for N-nitroso-desmethyl-tramadol (NDSRI) at the 24‑month stability interval. Consumers and healthcare providers should stop using the product immediately and contact Amneal for guidance.
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).
Consumers and healthcare providers should stop using this product immediately. Contact Amneal Pharmaceuticals, LLC or your healthcare provider for guidance
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Tramadol hydrochloride tablets are prescription analgesics used to treat moderate to moderately severe pain. They require a doctor’s prescription and are dispensed by pharmacies. This recall involves a large batch distributed nationwide.
The impurity NDSRI can pose health risks if ingested. The issue was detected during long-term stability testing at controlled storage conditions.
This recall is not described as part of a broader industry pattern.
Consumers exposed to the impurity could experience adverse effects. The recall presents an urgent safety action for patients currently taking the affected product.
FDA recall page and the Amneal recall notice through the FDA enforcement database.
Refund or replacement timelines are typically 4-6 weeks once the distributor processes the recall.
Keep packaging, lot numbers, expiry dates, receipts, and all recall communications for records.
Bottle count: 500 per bottle. Quantity recalled: 29,542 bottles. NDC: 60219-2348-5. Lot numbers: AM230987. Expiration dates: 05/2026 and 12/2026. Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India. Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141. Sold Rx only. Distribution: Nationwide in the USA.
No injuries or incidents have been reported.
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