Metoprolol Tartrate Tablets Recalled for Nitrosamine Contamination Above Safety Limits
Westminster Pharmaceuticals is recalling Metoprolol Tartrate 50 mg tablets nationwide due to contamination with N-nitroso-metoprolol exceeding safe intake limits. About 16,672 bottles are affected across multiple batches.
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: This is an FDA Class II recall involving contamination with N-nitroso-metoprolol above established safe intake levels. No illnesses or injuries have been reported, making this a risk-of-harm situation without reported injury.
Plain-English summary
Metoprolol Tartrate Tablets, USP, 50 mg are being recalled nationwide by Westminster Pharmaceuticals LLC due to a manufacturing defect.
The recall affects approximately 16,672 bottles of Metoprolol Tartrate Tablets, USP, 50 mg (1000-tablet count bottles) distributed nationwide. The affected batches and expiration dates are as follows: Batches R55230021, R55230031, R55230041 (Exp. 9/30/25); Batches R55230051, R55230061, R55230071, R55230081, R55230091, R55230101, R55230111, R55230121, R55230131, R55230141 (Exp. 10/31/2025); Batch R55230151 (Exp. 11/30/25); Batch R55240011 (Exp. 12/31/25); Batches R55240021, R55240031, R55240041, R55240051, R55240061 (Exp. 6/30/26); Batches R55240071, R55240081, R55240091, R55240101, R55240111, R55240121 (Exp. 7/31/26).
The tablets have been found to contain N-nitroso-metoprolol at levels exceeding the established Acceptable Daily Intake (ADI) limit due to Good Manufacturing Practice (CGMP) deviations. Persons who have been prescribed this medication should consult with their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- METOPROLOL TARTRATE (METOPROLOL TARTRATE)
- Brand
- METOPROLOL TARTRATE
- Manufacturer
- Westminster Pharmaceuticals LLC
- Category
- Drug — Beta-blocker
- Hazard
- nitrosamine
- manufacturing-defect
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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