Tretinoin Cream UPS 0.05% Recall: Impurity Out of Spec
Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Tretinoin Cream UPS 0.05% recalled?
Failed Impurities/Degradation Specifications
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Which lot codes, UPCs or models are affected?
Lot # AD96196, Exp Date: 12/31/2026.
- Agency record number
- D-0035-2027
- Product
- Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA…
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Quantity
- N/A
- Distribution
- US Nationwide.
- Recall started
- September 25, 2026
- Report date
- October 14, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)