FDA Drug · D-0597-2026

Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054. NDC: 67877-644-30

Class II · Ongoing

Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis

Affected lots / codes — check yours against thisLot# 25141635, Exp 4/30/2028

Recalling firm: Ascend Laboratories, LLC, Bedminster, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 360 30-count bottles
Distribution: Nationwide in the USA
Recall initiated: June 1, 2026
Classified: June 17, 2026
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0597-2026%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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