minolira (minocycline hydrochloride) extended-release tablets recall
FDA recall D-0475-2024 · initiated Apr 23, 2024
EPI Health, LLC recalled minolira (minocycline hydrochloride) extended-release tablets in Apr 2024 — an FDA Class II recall (D-0475-2024) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
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.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
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: 5664 bottles
Details
- Product
- 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.
- Recalling company
- EPI Health, LLC
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide
- Initiated
- Apr 23, 2024
- FDA report date
- May 1, 2024
Frequently asked
- Was minolira (minocycline hydrochloride) extended-release tablets recalled?
- EPI Health, LLC recalled minolira (minocycline hydrochloride) extended-release tablets in Apr 2024 — an FDA Class II recall (D-0475-2024) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was minolira (minocycline hydrochloride) extended-release tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0475-2024 was: 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.
- Is a recalled minolira (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 minolira (minocycline hydrochloride) extended-release tablets are affected?
- Distributed: US Nationwide. The recall covers these lots — lot# T2201700- exp. 02/28/2025 lot# T2201701- exp. 02/28/2025. 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-0475-2024.