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Recall Observatory FDA recall evidence

Drug 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.

D-0356-2026

January 29, 2026

Class II

Product summary

Firm
Teva Pharmaceuticals USA, Inc
Event
Event 98348
Status
Ongoing
Classification
Class II
Quantity
7,448 bottles
Official record key
drug-enforcement:D-0356-2026

Official wording

Reason: Failed Dissolution Specifications

Code information: Lot#: a) 0718J251, 0729J251, 0730J251, Exp.: 12/2026; b) 0718J252, 0729J252, 0730J252, Exp.: 12/2026.

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications