FDA Drug Recalls

Recalls / Class II

Class IID-0356-2026

Product

Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), 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) 0718J251, 0729J251, 0730J251, Exp.: 12/2026; b) 0718J252, 0729J252, 0730J252, Exp.: 12/2026.

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
7,448 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-0356-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: Metoprolol Succinate · FDA Drug Recalls