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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

EPI Health, LLC: Minolira (minocycline hydrochloride) Extended-Release Tablets Recalled

Agency Publication Date: September 25, 2019
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Summary

Approximately 1,626 five-count sample bottles of Minolira (minocycline hydrochloride) extended-release tablets, 135 mg, have been voluntarily recalled. These physician samples were found to have failed dissolution specifications, meaning the medication may not dissolve at the correct rate as intended. This defect can interfere with how the drug is absorbed by the body, potentially affecting its effectiveness.

Risk

If the medication fails to dissolve properly, the patient may not receive the intended therapeutic dose of minocycline, which could result in a lack of treatment efficacy for the underlying condition. There have been no reported injuries or adverse events associated with this recall to date.

What You Should Do

  1. Check your medication bottles for Minolira (minocycline hydrochloride) 135 mg extended-release tablets labeled as 'Physician Sample Not for Sale' in 5-count bottles.
  2. Verify the identifying details on the bottle: Look for Lot number T900093 and Expiration date 11/2020. The NDC (National Drug Code) printed on the label is 71403-102-05.
  3. Contact your healthcare provider or pharmacist immediately for guidance if you have this product or have been taking it.
  4. Return any unused physician samples to the place of purchase or your healthcare provider for a refund or replacement instructions.
  5. Contact the manufacturer, EPI Health, LLC, at their Charleston, SC office for further instructions regarding the return of these samples.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact healthcare provider and return product for refund.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund and contact the manufacturer for further instructions.

Affected Products

Product: minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physician Sample Not for Sale (5 Tablets)
Model:
NDC 71403-102-05
Recall #: D-0120-2020
Lot Numbers:
T900093 (Exp 11/2020)
Date Ranges: 11/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83809
Status: Resolved
Manufacturer: EPI Health, LLC
Sold By: EPI Field Representatives
Manufactured In: India, United States
Units Affected: 1,626 5-count bottles
Distributed To: Nationwide
Agency Last Updated: October 2, 2019

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.