Tretinoin Cream USP recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIIOngoing
Summary: SUN PHARMACEUTICAL INDUSTRIES INC is recalling 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.. Reason: Failed Impurities/Degradation Specifications.
What is being recalled
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.
Why
Failed Impurities/Degradation Specifications
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
US Nationwide.
How to tell if yours is affected
Lot # AD96183, Exp Date: 12/31/2026.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0034-2027 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | September 25, 2026 |
| Reported | October 14, 2026 |
| Company | SUN PHARMACEUTICAL INDUSTRIES INC |
| Company location | Princeton, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | N/A |
More recalls from SUN PHARMACEUTICAL INDUSTRIES INC · all drug recalls · recalls from September 2026