traMADol Hydrochloride Tablets recall
FDA recall D-0408-2026 · initiated Mar 19, 2026
Amneal Pharmaceuticals, LLC recalled traMADol Hydrochloride Tablets in Mar 2026 — an FDA Class II recall (D-0408-2026) because 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).
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
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).
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 29,542 bottles
Details
- 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.
- Recalling company
- Amneal
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the USA
- Initiated
- Mar 19, 2026
- FDA report date
- Apr 8, 2026
Frequently asked
- Was traMADol Hydrochloride Tablets recalled?
- Amneal Pharmaceuticals, LLC recalled traMADol Hydrochloride Tablets in Mar 2026 — an FDA Class II recall (D-0408-2026) because 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). May cause temporary or medically reversible harm; low probability of serious harm.
- Why was traMADol Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0408-2026 was: 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).
- Is a recalled traMADol Hydrochloride Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of traMADol Hydrochloride Tablets are affected?
- Distributed: Nationwide within the USA. The recall covers these lots — Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0408-2026.