Warning
Ascend Laboratories Recalls Minocycline Hydrochloride Extended-Release Tablets
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0597-2026Drug / Pharmaceutical
Ascend Laboratories Recalls Minocycline Hydrochloride Extended-Release Tablets
Ascend Laboratories, LLC · Class II — Moderate Risk
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
Reason for Recall
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Ascend Laboratories, LLC initiated the recall on June 1, 2026 affecting 360 30-count bottles. Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis. The product was distributed nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Ascend Laboratories, LLC for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.