Sun Pharmaceutical Industries Inc: Tretinoin Cream Usp, 0.05%
Tretinoin Cream Recall Summary Sun Pharmaceutical is recalling Tretinoin Cream USP 0.05% (a prescription acne and anti-aging medication) in 45-gram tubes because the product failed quality tests for impurities and degradation. The recalled product was distributed nationwide across all U.S. states and territories. This is a Class III recall, meaning the product is unlikely to cause serious health problems, but it does not meet quality standards.
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product
- Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9.
- Reason
- Failed Impurities/Degradation Specifications
- Classification
- Class III
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-09-25
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- US Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/875ebe5c-0221-444c-b2a3-bf26cb29f291