Sun Pharmaceutical Industries Tretinoin Cream Recall: Failed Impurity Specs (October 2026)
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SUN PHARMACEUTICAL INDUSTRIES INC is recalling three lots of Tretinoin Cream USP, 0.05%, sold in the US. The creams failed impurities and degradation specifications. The FDA classed the recall as Class III. If you have the product, stop using it and check the official notice or contact the company.
Is my product affected?
The recall covers Tretinoin Cream USP, 0.05%, prescription-only tubes in 45 g and 20 g sizes. Check the lot number and expiration date on your tube. All three lots expire 12/31/2026.
- 45 g tube, Rx only, made by Taro Pharmaceuticals Inc. and distributed by Taro Pharmaceuticals USA Inc., NDC 51672-1394-9.
- 45 g tube, made for Northstar Rx LLC by Taro Pharmaceuticals Inc., NDC 16714-249-02.
- 20 g tube, Rx only, made by Taro Pharmaceuticals Inc. and distributed by Taro Pharmaceuticals USA Inc., NDC 51672-1394-0.
| Detail | Value |
|---|---|
| Brand | Sun Pharmaceutical Industries |
| Product | Tretinoin Cream USP, 0.05%, 45g tube; Tretinoin Cream USP, 0.05%, 45 g tube; Tretinoin Cream UPS, 0.05%, 20g |
| FDA recall numbers | D-0033-2027, D-0034-2027, D-0035-2027 |
| Lot code (45 g, NDC 51672-1394-9) | AD96184 |
| Lot code (45 g, NDC 16714-249-02) | AD96183 |
| Lot code (20 g, NDC 51672-1394-0) | AD96196 |
| Expiration date | 12/31/2026 |
| NDC | 51672-1394-9 |
| NDC | 16714-249-02 |
| NDC | 51672-1394-0 |
What’s the hazard
The products failed impurities and degradation specifications. The FDA classed the recall as Class III: a situation where use of or exposure to the product is not likely to cause adverse health consequences.
What to do
Stop using the product and check the official notice or contact SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States.
The recall was started by the company on September 25, 2026, and is ongoing.
Where it was sold
Distributed across the US nationwide.
Source
Source: U.S. Food and Drug Administration (FDA), event 99977.
From our recall records
This is the first Sun Pharmaceutical Industries recall in our records (we track FDA notices since October 2026). Regulators issued 17 Drugs recalls in the 30 days up to this notice. That counts every notice we received, not only the ones written up here.
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