Quick Facts at a Glance
- Recall Date
- August 6, 2025
- Hazard Level
- HIGH
- Brands
- Metoprolol Tartrate, Westminster Pharmaceuticals
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, ELDERLY
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Metoprolol Tartrate, Westminster Pharmaceuticals
- Product type
- Metoprolol Tartrate Tablets
- Model numbers
- Batch # R56240011, Batch # R56240021, Batch # R56240031, Batch # R56240041, Batch # R56240051, Batch # R56240061, Batch # R56240071
- UPC codes
- 69367-354, 69367-355, 69367-354-10, 69367-354-01, 69367-355-10, 69367-355-01
- Sizes
- 1000-count bottles
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 6, 2025
Reported by FDA DRUG
August 20, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
CGMP Deviations: Presence of a nitrosamine, N-nitroso-metoprolol above the established Acceptable Daily Intake (ADI) level.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Westminster Pharmaceuticals LLC or your healthcare provider for guidance. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
Metoprolol Tartrate tablets are a beta-blocker used to treat high blood pressure and other heart-related conditions. They are prescribed by healthcare providers and distributed by medical suppliers.
Why This Is Dangerous
Nitrosamines are potential carcinogens. In this case, nitrosamine levels exceed the ADI due to CGMP deviations, prompting a nationwide recall.
Industry Context
This recall is not described as part of a broader industry pattern in the provided notice.
Real-World Impact
The recall affects patients currently taking this medication. Stop use until advised by a clinician. Replacement prescriptions may be necessary.
Practical Guidance
How to identify if yours is affected
- Verify bottle count 1000 tablets per bottle
- Confirm distributed by Westminster Pharmaceuticals
- Look for 100 mg strength on the label
Where to find product info
FDA recall page and Westminster Pharmaceuticals notices; contact healthcare provider
What timeline to expect
Notification and replacement/refund details will be communicated by Westminster Pharmaceuticals; expect weeks to process
If the manufacturer is unresponsive
- Document all attempts to contact the company
- Reach out to your pharmacy for guidance on interim treatment
- File a consumer complaint with the FDA if needed
How to prevent similar issues
- Ask for transparent CGMP certifications when acquiring meds
- Verify NDC before taking a medication
- Avoid mixing manufacturers without clear distribution lines
- Consult clinician before stopping any prescription drug
- Keep an updated list of medications and batch numbers
Documentation advice
Keep recall notice, photos of bottle, batch numbers, receipts, and correspondence with manufacturer
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Product Details
Brand: Metoprolol Tartrate. Distributor: Westminster Pharmaceuticals, LLC, Nashville, TN 37217. Type: Metoprolol Tartrate Tablets, USP, 100 mg, 1,000-count bottles. NDC: 69367-355-10. Manufactured by: Renata PLC General Plant-2, Gazipur, Bangladesh. Quantity: 4,456 bottles. Distribution: Nationwide in the USA. Recall Date: 2025-08-06. Report Date: 2025-08-20.
Reported Incidents
No specific incidents or injuries are mentioned in the recall notice.
Key Facts
- N-nitroso-metoprolol above ADI
- Manufactured in Bangladesh
- Distributed nationwide in the USA
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Safety Guide
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