Minocycline Hydrochloride Extended-Release Tablets recall
FDA recall D-0597-2026 · initiated Jun 1, 2026
Ascend Laboratories, LLC recalled Minocycline Hydrochloride Extended-Release Tablets in Jun 2026 — an FDA Class II recall (D-0597-2026) because Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 360 30-count bottles
Details
- 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
- Recalling company
- Ascend Laboratories, Ltd
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jun 1, 2026
- FDA report date
- Jun 17, 2026
Frequently asked
- Was Minocycline Hydrochloride Extended-Release Tablets recalled?
- Ascend Laboratories, LLC recalled Minocycline Hydrochloride Extended-Release Tablets in Jun 2026 — an FDA Class II recall (D-0597-2026) because Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Minocycline Hydrochloride Extended-Release Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0597-2026 was: Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
- Is a recalled Minocycline Hydrochloride Extended-Release Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Minocycline Hydrochloride Extended-Release Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot# 25141635, Exp 4/30/2028. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0597-2026.