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 # R55230021, Batch # R55230031, Batch # R55230041, Batch # R55230051, Batch # R55230061, Batch # R55230071, Batch # R55230081, Batch # R55230091 +8 more
- 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 is a beta-blocker used to treat high blood pressure and other heart-related conditions. It is prescribed and distributed as a generic medication.
Why This Is Dangerous
Nitrosamines are potential carcinogens. Exceeding ADI implies potential long-term cancer risk with prolonged exposure.
Real-World Impact
The recall affects patients relying on these tablets for cardiovascular conditions. It requires immediate termination of use and medical consultation for alternatives.
Practical Guidance
How to identify if yours is affected
- Confirm 50 mg strength and 1000-count bottle.
Where to find product info
NDC 69367-354-10 on label; batch number on bottle label.
What timeline to expect
Refunds or replacements typically take 4-8 weeks after verification.
If the manufacturer is unresponsive
- Document all contact attempts.
- Escalate to FDA or consumer protection offices if manufacturer remains unresponsive.
How to prevent similar issues
- For future drug recalls, monitor FDA recall notices and verify NDC and batch numbers before taking medications.
- Ask pharmacists for lot-specific safety updates.
- Be mindful of nitrosamine recalls in other medications.
Documentation advice
Keep all recall notices, bottle labels, batch numbers, and communications with pharmacy or provider. Save receipts and timelines.
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Product Details
Metoprolol Tartrate Tablets, USP, 50 mg, 1000-count bottles. Manufactured by Renata PLC (General Plant -2), Noyapara, Bhawal Mirzapur, Rajendrapur, Gazipur, 1700 Bangladesh. Distributed by Westminster Pharmaceuticals, LLC, Nashville, TN 37217. NDC 69367-354-10. Batch numbers include R55230021 through R55230151 and R55240011, R55240021. Quantity recalled: 16,672 bottles. Sold nationwide in the USA.
Reported Incidents
No injuries or incidents have been reported in the provided data.
Key Facts
- 16,672 1000-count bottles recalled
- N-nitroso-metoprolol exceeds ADI
- Nationwide distribution in the USA
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Safety Guide
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