FDA Drug Recalls

Recalls / Class II

Class IID-0357-2026

Product

Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054, NDC: 45963-678-11

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) 0686H251, 0687H251, 10688H251, Exp.: 02/2027. .

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
19,056 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-0357-2026. 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