Sun Pharmaceutical Industries Tretinoin Cream
Tretinoin Cream USP, 0.05% failed impurities and degradation specifications.
2 photos
What to do
What happened
SUN PHARMACEUTICAL INDUSTRIES INC began a recall of Tretinoin Cream UPS and Tretinoin Cream USP, 0.05% products on September 25, 2026, because they failed impurities and degradation specifications. The FDA added the recall to its Enforcement Report and classified it on October 8, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your tube affected?
3 products
Match the lot code and NDC listed under your product.
Tretinoin Cream UPS, 0.05%, 20g, Rx only
- NDC
- 51672-1394-0
- Lot
- AD96196
Tretinoin Cream USP, 0.05%, 45 g tube
- NDC
- 16714-249-02
- Lot
- AD96183
Tretinoin Cream USP, 0.05%, 45g tube, Rx only
- NDC
- 51672-1394-9
- Lot
- AD96184
Details
- Company began the recall
- Event ID
- 99977
- Company
- SUN PHARMACEUTICAL INDUSTRIES INC
- Hazard
- Impurity or degradation
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
