FDA recall D-0597-2026

Product

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2026-06-01

Report date

2026-06-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bedminster, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0597-2026