Sun Pharmaceutical Industries Inc: Tretinoin Cream Usp, 0.05%
Tretinoin Cream Recall Summary Sun Pharmaceutical is recalling Tretinoin Cream USP, 0.05% (a 45-gram tube used to treat acne and skin conditions) distributed nationwide because the product failed quality tests for impurities and degradation. The affected product was manufactured by Taro Pharmaceuticals in Canada and distributed under the Northstar Rx label. This is a Class III recall, the least serious classification, affecting consumers across all U.S. states and Washington, D.C.
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product
- Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product of Canada, NDC 16714-249-02.
- 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/b4791629-14be-417e-bc69-044fca980888