Minocycline Hydrochloride Tablet, Film Coated, Extended Release
FDA Recall NDC 67877-436
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Minocycline Hydrochloride (NDC 67877-436). A significant event, classified as Class II, was initiated on Jun 01, 2026 by Ascend Laboratories, Llc. The reported reason for this action was: "Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Jun 01, 2026
Jun 17, 2026
360 30-count bottles
Recall Profile & Regulatory Data
Event ID
99129
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Ascend Laboratories, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# 25141635, Exp 4/30/2028
Affected Packages Involved in this Recall
67877-578-14Product
67877-578-30Product
67877-578-01Product
67877-578-05Product
67877-576-14Product
67877-576-30Product
67877-576-01Product
67877-576-05Product
67877-577-14Product
67877-577-30Product
67877-577-01Product
67877-577-05Product
67877-643-14Product
67877-643-30Product
67877-643-01Product
67877-643-05Product
67877-644-14Product
67877-644-30Product
67877-644-01Product
67877-644-05Product
67877-436-14Product
67877-436-30Product
67877-436-01Product
67877-436-05Product
67877-437-14Product
67877-437-30Product
67877-437-01Product
67877-437-05Product
67877-438-14Product
67877-438-30Product
67877-438-01Product
67877-438-05Product
Class III Terminated
Failed Dissolution Specifications: low out of specification results for dissolution testing.
Jan 22, 2020
Feb 12, 2020
4728 bottles
Recall Profile & Regulatory Data
Event ID
84750
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Ascend Laboratories LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Termination Date
Oct 27, 2021
Product Description
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.
Batch or Lot Expiration Information
Lot# : 19140414, Exp 12/2020
Affected Packages Involved in this Recall
67877-578-14Product
67877-578-30Product
67877-578-01Product
67877-578-05Product
67877-576-14Product
67877-576-30Product
67877-576-01Product
67877-576-05Product
67877-577-14Product
67877-577-30Product
67877-577-01Product
67877-577-05Product
67877-643-14Product
67877-643-30Product
67877-643-01Product
67877-643-05Product
67877-644-14Product
67877-644-30Product
67877-644-01Product
67877-644-05Product
67877-436-14Product
67877-436-30Product
67877-436-01Product
67877-436-05Product
67877-437-14Product
67877-437-30Product
67877-437-01Product
67877-437-05Product
67877-438-14Product
67877-438-30Product
67877-438-01Product
67877-438-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
