Clindamycin Phosphate USP recall (SUN PHARMACEUTICAL INDUSTRIES INC)
DrugClass IIIOngoing
Summary: SUN PHARMACEUTICAL INDUSTRIES INC is recalling Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4. Reason: Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
What is being recalled
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel; Dist. by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC# 51672-4081-4
Why
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
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
Nationwide in the USA.
How to tell if yours is affected
Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025
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-0257-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | November 26, 2025 |
| Reported | January 21, 2026 |
| Company | SUN PHARMACEUTICAL INDUSTRIES INC |
| Company location | Princeton, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
More recalls from SUN PHARMACEUTICAL INDUSTRIES INC · all drug recalls · recalls from November 2025