Metoprolol tartrate 100 mg tablets exceed the nitrosamine daily intake level
Metoprolol Tartrate Tablets USP 100 mg distributed by Westminster Pharmaceuticals are being recalled because N-nitroso-metoprolol was present above the established Acceptable Daily Intake level. 4,456 bottles 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: Risk-of-harm product: a nitrosamine impurity measured above the named Acceptable Daily Intake level, with no injury reported in the source.
Plain-English summary
Metoprolol Tartrate Tablets, USP, 100 mg, 1000 tablets per bottle, prescription only, manufactured by Renata PLC of Gazipur, Bangladesh and distributed by Westminster Pharmaceuticals, LLC, is being recalled. The action covers 4,456 1000-count bottles.
The stated reason is CGMP deviations: the presence of a nitrosamine, N-nitroso-metoprolol, above the established Acceptable Daily Intake level. The FDA classified the action as Class II.
Affected batches include R56240011 expiring 2/28/26 and R56240021 and R56240031 expiring 3/31/26, together with the further batches listed in the recall notice. Distribution was nationwide in the USA.
Patients holding affected batches should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by the distributor.
The recalled product
- Product
- METOPROLOL TARTRATE (METOPROLOL TARTRATE)
- Brand
- METOPROLOL TARTRATE
- Manufacturer
- Westminster Pharmaceuticals LLC
- Category
- Drug — Oral tablet
- Hazard
- nitrosamine
- n-nitroso-metoprolol
- impurity-limit
- cgmp-deviation
- 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 (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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