Why it was recalled
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025
Where it was sold
Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0257-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Nov 26, 2025
- FDA report date
- Jan 21, 2026
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0257-2026, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98062
- Address
- 2 Independence Way
- Code information
- Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025
- Postal code
- 08540-6620
- Report date
- Jan 21, 2026
- Product type
- Drugs
- Recall number
- D-0257-2026
- Classification
- Class III
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Reason for recall
- Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Nov 26, 2025
- Initial firm notification
- Letter
- Center classification date
- Jan 14, 2026