FDA Drugs recall ·
Metoprolol Tartrate Tablets, USP, 50 mg, 1000 Tablets, Rx Only… recall
- Recall number
- D-0581-2025
- Date
- (initiated August 6, 2025)
- Company / brand
- Westminster Pharmaceuticals LLC
1321 Murfreesboro Pike Ste 607, Nashville, TN, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 16,672 1000-count bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Batch # R55230021, R55230031, R55230041, Exp Date: 9/30/25; Batch # R55230051, R55230061, R55230071, R55230081, R55230091, R55230101, R55230111, R55230121, R55230131, R55230141, Exp Date: 10/31/2025; Batch # R55230151, Exp Date: 11/30/25; Batch # R55240011, Exp Date: 12/31/25; Batch # R55240021, R55240031, R55240041, R55240051, R55240061, Exp Date: 6/30/26; Batch # R55240071, R55240081, R55240091, R55240101, R55240111, R55240121, Exp Date: 7/31/26
Distribution
Nationwide in the USA.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0581-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.