FDA-Drug2026-10-14Class IIICHEMICAL
Sun Pharmaceutical tretinoin cream 0.05% recalled for failed impurity specifications
What this means
Sun Pharmaceutical is recalling one lot of tretinoin cream 0.05% because it failed quality testing for impurities and degradation. The affected lot (AD96184, expiring 12/31/2026) was distributed nationwide. No injuries have been reported.
- Check if your tretinoin cream matches lot number AD96184 (printed on the box or tube).
- If you have this lot, contact your pharmacist or doctor before continuing use.
- Do not use the product if you have the recalled lot number.
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%, 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0033-2027More Sun Pharmaceutical recalls
- FDA-Drug2026-10-14Sun Pharmaceutical tretinoin cream 0.05% recalled for failed impurity and degradation 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
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