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

Recall Number: D-0597-2026

Firm: Ascend Laboratories, LLC

Classification: Class II

Status: Ongoing

Report Date: 20260617

Initiation Date: 20260601

Termination Date:

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

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