Metoprolol tartrate tablets recalled for nitrosamine above acceptable daily intake level
Metoprolol Tartrate Tablets USP, 50 mg, distributed by Westminster Pharmaceuticals, are recalled nationwide after N-nitroso-metoprolol was found above the established Acceptable Daily Intake. 16,672 bottles are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; a nitrosamine above the Acceptable Daily Intake is a potential harm and no injuries are reported.
Plain-English summary
Metoprolol Tartrate Tablets, USP, 50 mg, in 1000-count bottles and available on prescription only, are being recalled. The product is manufactured by Renata PLC in Gazipur, Bangladesh and distributed by Westminster Pharmaceuticals, LLC of Nashville, Tennessee. Affected batches include R55230021, R55230031 and R55230041 with an expiry of 9/30/25, along with batches R55230051, R55230061, R55230071 and R55230081. The recall covers 16,672 1000-count bottles distributed nationwide.
The recall follows current good manufacturing practice deviations: the presence of a nitrosamine, N-nitroso-metoprolol, above the established Acceptable Daily Intake level. The FDA classified the action as Class II.
Patients should check the batch number on their bottle against the list above and should not stop taking a prescribed medicine without speaking to their pharmacist or prescriber about a replacement supply.
The recalled product
- Product
- METOPROLOL TARTRATE (METOPROLOL TARTRATE)
- Brand
- METOPROLOL TARTRATE
- Manufacturer
- Westminster Pharmaceuticals LLC
- Category
- Drug — Cardiovascular
- Hazard
- nitrosamine-impurity
- cgmp-deviation
- prescription-drug
- class-ii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
UPCs (3)
- 0369367355018
- 0369367354103
- 0369367354011
Distribution
Distributed nationwide across the United States.
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