FDA-Drug2026-10-14Class IIICHEMICAL
Sun Pharmaceutical tretinoin cream 0.05% recalled for failed impurity and degradation specifications
What this means
Sun Pharmaceutical's tretinoin cream 0.05% (a prescription acne and anti-aging medication) failed quality testing for impurities and degradation. One lot is affected: #AD96196, expiring 12/31/2026. The product was distributed nationwide.
- Check if you have lot #AD96196 (printed on the box or tube).
- Contact your pharmacy or prescriber if you have this lot.
- Do not use the affected medication without guidance from your pharmacist or doctor.
- Return the medication to your pharmacy for a replacement or refund.
The agency's original wording
Hazard
Failed Impurities/Degradation Specifications
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide.
Affected count
N/A
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0035-2027More Sun Pharmaceutical recalls
- FDA-Drug2026-10-14Sun Pharmaceutical tretinoin cream 0.05% recalled for failed impurity specifications
- FDA-Drug2026-10-14Sun Pharmaceutical tretinoin cream recalled for failed impurity specifications
- FDA-Drug2026-09-23Sun Pharmaceutical Nystatin Cream recalled for failed stability specifications
- FDA-Drug2026-08-26Sun Pharmaceutical Carbamazepine 200mg tablets recalled for manufacturing defect
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.