CLASS II Drug recall · Reported 1 May 2024 · FDA Enforcement Report
minolira (minocycline hydrochloride) extended-release tablets, 135mg recalled
EPI Health is recalling minolira (minocycline hydrochloride) extended-release tablets, 135mg, distributed nationwide in the US. The recall was initiated on 23 Apr 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0475-2024
- FDA event ID
- 94447
- Recalling firm
- EPI Health, Charleston, SC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Apr 2024
- FDA classified
- 25 Apr 2024
- Reported
- 1 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 23 Apr 2024 | Recall initiated by company | |
| 25 Apr 2024 | Classified by FDA | +2 days |
| 1 May 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide
Questions about this recall
Why was it 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.
Which lots are affected?
lot# T2201700- exp. 02/28/2025 lot# T2201701- exp. 02/28/2025
Where was it sold?
US Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 94447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cloderm (clocortolone pivalate) Cream recalled by EPI Health | EPI Health | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | minolira (minocycline hydrochloride) extended-release tablets, 105mg recalled | EPI Health | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from EPI Health
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | minolira (minocycline hydrochloride) extended-release tablets, 105mg recalled | EPI Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cloderm (clocortolone pivalate) Cream recalled by EPI Health | EPI Health | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | minolira (minocycline hydrochloride) extended-release recalled | EPI Health | Potency & Assay | SC |
Other Minolira (minocycline recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | minolira (minocycline hydrochloride) extended-release tablets, 105mg recalled | EPI Health | Manufacturing (CGMP) Deviations | Nationwide |