Quick Facts at a Glance
- Recall Date
- August 20, 2025
- Hazard Level
- HIGH
- Brands
- Major Pharmaceuticals, CARVEDILOL
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT
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
- Major Pharmaceuticals, CARVEDILOL
- Product type
- Carvedilol Tablets 12.5 mg
- Model numbers
- Lot #: T05693, Exp. Date 03/2026
- UPC codes
- 0904-7305, 0904-7306, 0904-7307, 0904-7308, 0904-7305-61, 0904-7306-61, 0904-7307-61, 0904-7308-61
- Sizes
- 100-tablet carton
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
August 20, 2025
Reported by FDA DRUG
August 27, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your healthcare provider for guidance. Notification method: Letter
About This Product
Carvedilol is a beta-blocker used to treat high blood pressure and heart failure. Manufacturers distribute in tablet form to patients nationwide.
Why This Is Dangerous
NNCI impurity above FDA limits could pose health risks; exact clinical implications depend on exposure and patient factors.
Industry Context
This recall is not described as part of a broader pattern in the provided data.
Real-World Impact
The recall requires patients and healthcare providers to review exposure, discontinue use where advised, and coordinate replacements or alternatives.
Practical Guidance
How to identify if yours is affected
- Check package for NDC 0904-7307-61
- Look for Lot T05693 and Exp. 03/2026
- Verify packaging indicates Major Pharmaceuticals and Rugby Laboratories
Where to find product info
FDA recall page linked in enforcement report; manufacturer letters to healthcare providers
What timeline to expect
Processing and guidance to be provided via recall letters; replacements or refunds depend on provider and distributor timelines
If the manufacturer is unresponsive
- Escalate to FDA MedWatch
- Contact state pharmacy board
- Seek guidance from healthcare provider on alternatives
How to prevent similar issues
- Verify NDC numbers before dispensing prescriptions
- Monitor for NNCI-related recalls in drug databases
- Keep patients informed about recall notices
Documentation advice
Keep recall letters, patient exposure records, and communications with pharmacy or provider as documentation
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Product Details
Product: Carvedilol Tablets USP, 12.5 mg, 100-tablet carton. Packaged and distributed by Major Pharmaceuticals, Indianapolis, IN 46268, USA. NDC 0904-7307-61. Lot: T05693. Expiration: 03/2026. Quantity: 26,628 cartons. Distribution: Nationwide in the United States.
Reported Incidents
No specific patient incidents or injuries are detailed in the recall notice. Hazard is chemical impurity risk; no incident counts provided.
Key Facts
- NNCI impurity above 4.0 ppm
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Safety Guide
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