Recalls / Class II
Class IID-0582-2025
Product
Metoprolol Tartrate Tablets, USP, 100 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 69367-355-10
- Brand name
- Metoprolol Tartrate
- Generic name
- Metoprolol Tartrate
- Active ingredient
- Metoprolol Tartrate
- Route
- Oral
- NDCs
- 69367-354, 69367-355
- FDA application
- ANDA074453
- Affected lot / code info
- Batch # R56240011, Exp Date: 2/28/26; Batch # R56240021, R56240031, Exp Date: 3/31/26; Batch # R56240041, R56240051, R56240061, Exp Date: 4/30/26; Batch # R56240071, Exp Date: 7/31/26
Why it was recalled
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
Recalling firm
- Firm
- Westminster Pharmaceuticals LLC
- Manufacturer
- Westminster Pharmaceuticals, LLC
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1321 Murfreesboro Pike Ste 607, N/A, Nashville, Tennessee 37217-2693
Distribution
- Quantity
- 4,456 1000-count bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2025-08-06
- FDA classified
- 2025-08-12
- Posted by FDA
- 2025-08-20
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0582-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.