CLASS II ONGOING Drug recall · Reported 8 Apr 2026 · FDA Enforcement Report
traMADol Hydrochloride Tablets, USP, 50 mg recalled
Amneal Pharmaceuticals is recalling traMADol Hydrochloride Tablets, USP, 50 mg, distributed nationwide in the US. The recall was initiated on 19 Mar 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0408-2026
- FDA event ID
- 98623
- Recalling firm
- Amneal Pharmaceuticals, Bridgewater, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 19 Mar 2026
- FDA classified
- 30 Mar 2026
- Reported
- 8 Apr 2026
- Type
- Voluntary: Firm initiated
- Reason category
- Nitrosamine Impurity
- Drug class
- Pain Medication
Timeline
| 19 Mar 2026 | Recall initiated by company | |
| 30 Mar 2026 | Classified by FDA | +11 days |
| 8 Apr 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for 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).
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the USA
Questions about this recall
Why was it 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).
Which lots are affected?
Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.
Where was it sold?
Nationwide within the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 2 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Tramadol recalls
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP 50 mg recalledTramadol Hydrochloride | Rubicon Research Private | Other | Nationwide |
| Drug | CLASS II | TraMADol HCl, Packaged as (a) recalled by RemedyRepack | RemedyRepack | Packaging Defects | Nationwide |
| Drug | CLASS II | Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose Tablets recalled | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Tramadol Hydrochloride Tablets USP 100mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS III | Tramadol Hydrochloride Tablets, USP, 50 mg recalled | Golden State Medical Supply | Packaging Defects | Nationwide |