Drug Recall: 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 070
Ascend Laboratories, LLC · June 1, 2026
Reason for Recall
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Product Description
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
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
360 30-count bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0597-2026
Status: ongoing
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