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Class II · ModerateActive recall

Tramadol Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
Where it was soldNationwide within the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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).

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byAmneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glasgow, KY 42141 foreign manufacturer
Brand nameTRAMADOL HYDROCHLORIDE
Generic nameTRAMADOL HYDROCHLORIDE
Active ingredient(s)TRAMADOL HYDROCHLORIDE
Distributed by / forAmneal Pharmaceuticals LLC, Glasgow, KY 42141
NDC60219-2348-5
Show the full FDA record
Full product labeltraMADol 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.
Recalling firmAmneal Pharmaceuticals, LLC
DistributionNationwide within the USA
Quantity29,542 bottles
Recall initiated2026-03-19
Report date2026-04-08
Recall completed—
Recall numberD-0408-2026
ClassificationClass II
FDA statusOngoing
Origin on fileBridgewater NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.