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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 12,808
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by EPI Health, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · EPI Health, LLC
See all →- HighMinolira extended-release tablets recalled due to discontinued quality assurance program
FDA (Drugs) · 2024-05-01
- HighCloderm Cream Recalled for Manufacturer Quality Assurance Program Discontinuation
FDA (Drugs) · 2024-05-01
- LowEPI Health Recalls Minolira Tablets for Dissolution Failures
FDA (Drugs) · 2019-10-02
Similar recalls
- LowEPI Health Recalls Minolira Tablets for Dissolution Failures
FDA (Drugs) · 2019-10-02
- ModerateMinocycline extended-release tablets failed dissolution testing during stability analysis
FDA (Drugs) · 2026-06-17
- ModerateAscend Recalls Minocycline Hydrochloride Tablets for Dissolution Failures
FDA (Drugs) · 2020-02-12
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-11-11
- SevereMetformin Hydrochloride Extended-Release Tablets Recalled for NDMA Contamination
FDA (Drugs) · 2022-02-02
- HighMorphine Sulfate Extended-Release Tablets Recalled for Failed Impurities Specification
FDA (Drugs) · 2024-11-13