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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Cloderm Cream and Minolira Tablets Recalled for Quality Control Issues

Agency Publication Date: April 25, 2024
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Summary

EPI Health, LLC is recalling 37,117 units of Cloderm (clocortolone pivalate) Cream and Minolira (minocycline hydrochloride) extended-release tablets due to quality control failures at the manufacturing facility. This recall includes Cloderm 45g tubes and Minolira tablets in both 105mg and 135mg strengths. The recall was initiated because the manufacturer discontinued the quality program designed to ensure these medications meet the required identity, strength, and purity standards. Consumers should contact their healthcare provider or pharmacist for a refund or guidance on replacement therapy.

Risk

The lack of a proper quality assurance program means the manufacturer cannot guarantee the medication contains the correct amount of active ingredient or meets safety standards for purity. This could lead to patients receiving ineffective treatment or unexpected side effects from the medication.

What You Should Do

  1. The recalled products include Cloderm (clocortolone pivalate) 0.1% Cream (NDC 71403-804-90) and Minolira (minocycline hydrochloride) extended-release tablets in 105mg (NDC 71403-101-30) and 135mg (NDC 71403-102-30) strengths.
  2. Check your medication packaging for the following lot numbers and expiration dates: Cloderm lots SDFC- (Exp 5/31/2024) or TFBW- (Exp 5/31/2025); Minolira 105mg lots T2300765- (Exp 11/30/2025), T2201702A (Exp 02/28/2025), T2201699- (Exp 2/28/2025), or T2201698- (Exp 2/28/2025); and Minolira 135mg lots T2201700- (Exp 02/28/2025) or T2201701- (Exp 02/28/2025).
  3. If you have health concerns or are unsure if your medication is affected, contact your healthcare provider or pharmacist.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer, EPI Health, LLC, for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund.
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cloderm (clocortolone pivalate) Cream, 0.1% (45g)
Variants: Topical Cream, 0.1%
Lot Numbers:
SDFC- (Exp 5/31/2024)
TFBW- (Exp 5/31/2025)
NDC:
71403-804-90

Quantity: 18,645 tubes.

Product: minolira (minocycline hydrochloride) extended-release tablets (105mg 30-count)
Variants: Extended-release tablet, 105mg, 30-count bottle
Lot Numbers:
T2300765- (Exp 11/30/2025)
T2201702A (Exp 02/28/2025)
T2201699- (Exp 2/28/2025)
T2201698- (Exp 2/28/2025)
NDC:
71403-101-30

Quantity: 12,808 bottles.

Product: minolira (minocycline hydrochloride) extended-release tablets (135mg 30-count)
Variants: Extended-release tablet, 135mg, 30-count bottle
Lot Numbers:
T2201700- (Exp 02/28/2025)
T2201701- (Exp 02/28/2025)
NDC:
71403-102-30

Quantity: 5,664 bottles.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94447
Status: Resolved
Manufacturer: EPI Health, LLC
Sold By: Pharmacies; Healthcare Providers
Manufactured In: United States, India
Units Affected: 3 products (18645 tubes; 12808 bottles; 5664 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.