Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
3 recalls
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Class II Ongoing
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: 67877-644-3…
Reason: Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis
Lots, distribution and 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
- Lots / codes
- Lot# 25141635, Exp 4/30/2028
- Distribution
- Nationwide in the USA
- Quantity
- 360 30-count bottles
- Recall started
- June 1, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0597-2026
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Class II Terminated
minolira (minocycline hydrochloride) extended-release tablets, 135mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-102-30.
Reason: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Lots, distribution and details
- Lots / codes
- lot# T2201700- exp. 02/28/2025 lot# T2201701- exp. 02/28/2025
- Distribution
- US Nationwide
- Quantity
- 5664 bottles
- Recall started
- April 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0475-2024
-
Class II Terminated
minolira (minocycline hydrochloride) extended-release tablets, 105mg 30-count Bottle, Rx Only, Mfg by: Dr Reddy's Laboratories Limited, INDIA, Manufactured for: EPI Health, LLC, Charleston, SC 29403, NDC 71403-101-30.
Reason: CGMP Deviation: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
Lots, distribution and details
- Lots / codes
- lot # T2300765- exp. 11/30/2025 lot# T2201702A-exp. 02/28/2025 lot# T2201699- exp. 2/28/2025 lot# T2201698- exp. 2/28/2025
- Distribution
- US Nationwide
- Quantity
- 12808 bottles
- Recall started
- April 23, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0474-2024
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.