Metoprolol Tartrate Tablets Recalled for Nitrosamine Contamination Above Safety Limits
Westminster Pharmaceuticals is recalling 4,456 bottles of metoprolol tartrate tablets due to the presence of nitrosamine above the established safety limit.
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 a chemical impurity (nitrosamine) exceeding the established safety limit (ADI). The rubric designates risk-of-harm products where injury has not yet been reported as High (3), which applies to nitrosamine contamination above established safety thresholds.
Plain-English summary
Westminster Pharmaceuticals LLC is recalling 4,456 bottles of Metoprolol Tartrate Tablets, USP, 100 mg, distributed nationwide in the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Testing detected the presence of N-nitroso-metoprolol, a nitrosamine impurity, at levels above the established Acceptable Daily Intake (ADI).
The affected product includes multiple batches with expiration dates ranging from February 28, 2026 to July 31, 2026. Consumers should check with their pharmacy to determine if their medication supply includes any recalled batches.
Patients taking this medication should contact their healthcare provider with questions about their supply.
The recalled product
- Product
- METOPROLOL TARTRATE (METOPROLOL TARTRATE)
- Brand
- METOPROLOL TARTRATE
- Manufacturer
- Westminster Pharmaceuticals LLC
- Hazard
- nitrosamine
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 (11)
- 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
UPCs (3)
- 0369367355018
- 0369367354103
- 0369367354011
Distribution
Distributed nationwide across the United States.
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