Recalls / Class II
Class IID-0355-2026
Product
Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
- Brand name
- Metoprolol Succinate
- Generic name
- Metoprolol Succinate
- Active ingredient
- Metoprolol Succinate
- Route
- Oral
- NDCs
- 45963-676, 45963-709, 45963-677, 45963-678
- FDA application
- ANDA204161
- Affected lot / code info
- Lot#: a) 0486G251, 0487G251, 0488G251, Exp.: 01/2027; b) 0486G252, 0487G253, 0488G252, Exp.: 01/2027.
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Teva Pharmaceuticals USA, Inc
- Manufacturer
- Actavis Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Interpace Pkwy Bldg A, N/A, Parsippany, New Jersey 07054-1120
Distribution
- Quantity
- 67,043 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2026-01-29
- FDA classified
- 2026-02-27
- Posted by FDA
- 2026-03-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0355-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.