Minocycline Extended-Release Tablets Recalled for Manufacturing Quality Control Failure
EPI Health is recalling minolira extended-release tablets due to manufacturer discontinuation of quality control programs affecting product identity, strength, and purity. The recall covers 12,808 bottles distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for manufacturing quality program discontinuation affecting product identity, strength, quality, and purity. No illnesses or injuries reported; the hazard is a failure in manufacturing controls that could affect critical drug characteristics.
Plain-English summary
EPI Health, LLC is recalling minolira (minocycline hydrochloride) extended-release tablets, 105mg, 30-count bottles distributed nationwide. The recall affects 12,808 bottles.
The manufacturer discontinued its quality program that ensures the product meets required standards for identity, strength, quality, and purity. This manufacturing control deviation could result in products that do not meet established specifications.
Affected lot numbers include: T2300765 (expires 11/30/2025), T2201702A (expires 02/28/2025), T2201699 (expires 02/28/2025), and T2201698 (expires 02/28/2025). The product NDC is 71403-101-30.
Patients taking this medication should consult their healthcare provider before taking any action. Do not stop taking medication without medical guidance. Return affected bottles to the pharmacy where they were obtained.
The recalled product
- Product
- 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.
- Manufacturer
- EPI Health, LLC
- Category
- Drug — Antibiotic
- Hazard
- drug-quality
- cgmp-violation
Distribution
Distributed nationwide across the United States.
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