traMADol Hydrochloride Tablets, USP, 50 mg, 500-count… was recalled on March 19, 2026 in cooperation with the U.S. Food and Drug Administration because failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month…
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 #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
Units affected: 29,542 bottles
Where it was sold: Nationwide within the USA
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this 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).
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Amneal Pharmaceuticals, LLC
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Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
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