FDA DrugsClass II
traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufac...
Published: April 8, 2026Recall ID: D-0408-2026Category: drugsCountry: US
Reason for Recall / Hazard
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).
Product Description & Identification
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.
Affected Products
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Bridgewater |
| State | NJ |
| Openfda › Unii | 9N7R477WCK |
| Openfda › Route | ORAL |
| Openfda › Rxcui | 835603 |
| Openfda › Spl id | 12ec39ff-7a96-4467-a778-7537868c0ccd |
| Openfda › Brand name | TRAMADOL HYDROCHLORIDE |
| Openfda › Spl set id | 8ec4e4e5-a56e-4198-8428-6b770b9bf27d |
| Openfda › Package ndc › 1 | 60219-2348-4 |
| Openfda › Package ndc › 2 | 60219-2348-1 |
| Openfda › Package ndc › 3 | 60219-2348-5 |
| Openfda › Package ndc › 4 | 60219-2348-7 |
| Openfda › Product ndc | 60219-2348 |
| Openfda › Generic name | TRAMADOL HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | TRAMADOL HYDROCHLORIDE |
| Openfda › Manufacturer name | Amneal Pharmaceuticals NY LLC |
| Openfda › Application number | ANDA076003 |
| Openfda › Is original packager | true |
| Event id | 98623 |
| Address 1 | 400 Crossing Blvd Fl 3 |
| Code info | Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026. |
| Postal code | 08807-2863 |
| Report date | 20260408 |
| Product type | Drugs |
| Product quantity | 29,542 bottles |
| 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). |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260319 |
| Center classification date | 20260330 |
Overview
- Recalling FirmAmneal Pharmaceuticals, LLC
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the USA