Metoprolol Tartrate Tablets — Class II drug recall D-0581-2025
Ongoing recall by Westminster Pharmaceuticals LLC, reported 2025-08-20, distributed nationwide. CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake
| Recall number | D-0581-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Westminster Pharmaceuticals LLC, Nashville, TN, United States |
| Recall initiated | 2025-08-06 |
| Classified | 2025-08-12 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Reason classes | chemical contamination, cgmp |
| NDC | 69367-0354-10 |
| Lot numbers | R55230021, R55230031, R55230041, R55230051, R55230061, R55230071, R55230081, R55230091, R55230101, R55230111, R55230121, R55230131, R55230141, R55230151, R55240011, R55240021, R55240031, R55240041, R55240051, R55240061, R55240071, R55240081, R55240091, R55240101, R55240111, R55240121 |
| Expiration dates | 2025-09-30, 2025-10-31, 2025-11-30, 2025-12-31, 2026-06-30, 2026-07-31 |
Product
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Manufactured by: Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217, NDC 69367-354-10
Reason for recall
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0581-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.