CLASS III Drug recall · Reported 2 Oct 2019 · FDA Enforcement Report
minolira (minocycline hydrochloride) extended-release recalled
EPI Health is recalling minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample. The recall was initiated on 26 Aug 2019 and the FDA has classified it as Class III.
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-0120-2020
- FDA event ID
- 83809
- Recalling firm
- EPI Health, Charleston, SC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 26 Aug 2019
- FDA classified
- 2 Oct 2019
- Reported
- 2 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
Timeline
| 26 Aug 2019 | Recall initiated by company | |
| 2 Oct 2019 | Classified by FDA | +37 days |
| 2 Oct 2019 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications:
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale 5 Tablets, Rx Only, Mfg by: Dr. Reddy's Laboratories Limited, FTO-SEZ, Process Unit-01 Devunipalavalasa Village Srikakulam (District) Andhra Pradesh, INDIA. Manufactured for: EPI Health, LLC 134 Columbus St. Charleston, SC 29403 USA. NDC 71403-102-05.
Where it was distributed
Firm recalling only from EPI Field Representatives.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications:
Which lots are affected?
Lot# T900093, Exp 11/2020
Where was it sold?
Firm recalling only from EPI Field Representatives.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
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 II | minolira (minocycline hydrochloride) extended-release tablets, 135mg recalled | EPI Health | Manufacturing (CGMP) Deviations | Nationwide |