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Recall Observatory FDA recall evidence

Drug product

Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.

D-0547-2026

April 27, 2026

Class II

Product summary

Firm
Ascend Laboratories, LLC
Event
Event 98821
Status
Ongoing
Classification
Class II
Quantity
17,304 100-count bottles
Official record key
drug-enforcement:D-0547-2026

Official wording

Reason: Failed Dissolution Specifications

Code information: Lot # 25140859; Exp. Date: Jan 2027

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications