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Recall Observatory FDA recall evidence

Drug product

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

D-0357-2026

January 29, 2026

Class II

Product summary

Firm
Teva Pharmaceuticals USA, Inc
Event
Event 98348
Status
Ongoing
Classification
Class II
Quantity
19,056 bottles
Official record key
drug-enforcement:D-0357-2026

Official wording

Reason: Failed Dissolution Specifications

Code information: Lot#: a) 0686H251, 0687H251, 10688H251, Exp.: 02/2027. .

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications