FDA-Drug2026-10-14Class IIICHEMICAL
Sun Pharmaceutical tretinoin cream recalled for failed impurity specifications
What this means
Sun Pharmaceutical's tretinoin cream 0.05% (Lot #AD96183, expiring 12/31/2026) failed quality testing for impurities and degradation. The affected product was distributed nationwide. No injuries have been reported.
- Check if you have tretinoin cream with Lot #AD96183 (NDC 16714-249-02)
- Contact your pharmacy or doctor if you have this lot
- Do not use the product; return it to your pharmacy
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 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0034-2027More Sun Pharmaceutical recalls
- FDA-Drug2026-10-14Sun Pharmaceutical tretinoin cream 0.05% recalled for failed impurity specifications
- FDA-Drug2026-10-14Sun Pharmaceutical tretinoin cream 0.05% recalled for failed impurity and degradation 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.