FDA Drugs recall ·
Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg… recall
- Recall number
- D-0597-2026
- Date
- (initiated June 1, 2026)
- Company / brand
- Ascend Laboratories, LLC
135 Us Highway 202 206 Ste 15, Bedminster, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 360 30-count bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# 25141635, Exp 4/30/2028
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0597-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.