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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/Topical Products

Direct Rx Triamcinolone Acetonide Cream Recalled for Gritty Texture

Agency Publication Date: September 15, 2022
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Summary

Direct Rx is recalling 20 tubes of Triamcinolone Acetonide cream (0.1%) because of reports that the product has a gritty texture and is not working as expected. The recall affects 80 g tubes of this prescription skin medication that were distributed to physicians and medical facilities in Georgia and Idaho. If you have been using this cream, you should contact your doctor or pharmacist to discuss an alternative treatment.

Risk

The product's gritty texture and lack of effectiveness mean it may not properly treat the skin conditions for which it was prescribed. While no injuries have been reported, the medication's failure to provide the intended therapeutic effect could lead to untreated symptoms.

What You Should Do

  1. This recall involves 80 g tubes of Triamcinolone Acetonide cream (0.1%) with NDC 72189-330-80, identified by lot number 12JY2216 and an expiration date of 2/29/24.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

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: Triamcinolone Acetonide cream, 0.1% (80 g tube)
Variants: 0.1% strength, 80 g tube, Rx only
Lot Numbers:
12JY2216 (Exp. 2/29/24)
NDC:
72189-330-80

Packaged and Distributed By: Direct Rx, Dawsonville, GA; Dist. By Perrigo, Allegan, MI; Recall #: D-1535-2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 90869
Status: Resolved
Manufacturer: Direct Rx
Sold By: Physicians; Medical Facilities
Manufactured In: United States
Units Affected: 20 tubes
Distributed To: Georgia, Idaho

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.