Class II · ModerateActive recall
Metoprolol Tartrate
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberBatch # 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
Where it was soldNationwide in the USA.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byRenata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh, Distributed by: Westminster Pharmaceuticals, LLC, Nashville, TN 37217
| Brand name | METOPROLOL TARTRATE |
| Generic name | METOPROLOL TARTRATE |
| Active ingredient(s) | METOPROLOL TARTRATE |
| Distributed by / for | Westminster Pharmaceuticals, LLC, Nashville, TN 37217 |
| NDC | 69367-355-10 |
Show the full FDA record
| Full product label | 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 |
| Recalling firm | Westminster Pharmaceuticals LLC |
| Distribution | Nationwide in the USA. |
| Quantity | 4,456 1000-count bottles |
| Recall initiated | 2025-08-06 |
| Report date | 2025-08-20 |
| Recall completed | — |
| Recall number | D-0582-2025 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Nashville TN United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.