Skip to content
Back to recalls
Drug FDA Class II Ongoing Failed specifications

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

Ascend Laboratories, LLC Published Jun 17, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Ascend Laboratories, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Failed Dissolution · primary

Affected products (1)

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

MINOCYCLINE HYDROCHLORIDE · 360 30-count bottles

NDC: 67877-436, 67877-578, 67877-576, 67877-577, 67877-643, 67877-644, 67877-437, 67877-438, 67877-578-14, 67877-578-30, 67877-578-01, 67877-578-05, 67877-576-14, 67877-576-30, 67877-576-01, 67877-576-05, 67877-577-14, 67877-577-30, 67877-577-01, 67877-577-05, 67877-643-14, 67877-643-30, 67877-643-01, 67877-643-05, 67877-644-14, 67877-644-30, 67877-644-01, 67877-644-05, 67877-436-14, 67877-436-30, 67877-436-01, 67877-436-05, 67877-437-14, 67877-437-30, 67877-437-01, 67877-437-05, 67877-438-14, 67877-438-30, 67877-438-01, 67877-438-05
Lot codes: 25141635
Code info: Lot# 25141635, Exp 4/30/2028

Affected areas

Nationwide

Timeline

  1. Initiated
    Jun 1, 2026
  2. Published
    Jun 17, 2026
Recall number
D-0597-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.