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

FDA recall notice · announced June 17, 2026 · Ascend Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

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

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot# 25141635, Exp 4/30/2028
Quantity: 360 30-count bottles
Status: Ongoing
Products in this recall event:
- 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 (D-0597-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.