Sun Pharmaceutical Industries Inc: Tretinoin Cream Ups, 0.05%

Tretinoin Cream Recall Summary Sun Pharmaceutical is recalling Tretinoin Cream 0.05% (a prescription acne and anti-aging medication) in 20-gram tubes distributed nationwide because the product failed quality tests for impurities and degradation. The affected product has NDC number 51672-1394-0 and was manufactured by Taro Pharmaceuticals in Canada. This is a Class III recall, meaning use of the product is unlikely to cause serious health problems.

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Product
Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-0.
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/094ec65a-2a90-4d28-97d0-9fab25fb6d9e