FDA-Drug2026-01-21Class IIICHEMICAL
Sun Pharmaceutical clindamycin topical solution recalled for impurity and potency issues
What this means
Sun Pharmaceutical has recalled three lots of clindamycin phosphate 1% topical solution due to failed quality tests. The affected batches contain higher-than-acceptable impurities and may not contain the correct amount of active ingredient, which could reduce effectiveness.
- Check your clindamycin bottle for lot numbers AD30154, AD31143, or AD31145 with expiration date 11/30/2025
- Stop using the medication if you have one of these lots
- Contact your pharmacy or doctor for a replacement prescription
- Do not flush or throw the medication in the trash; ask your pharmacy how to safely dispose of it
The agency's original wording
Hazard
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA.
Manufactured in
2 Independence Way, Princeton, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0257-2026More Sun Pharmaceutical recalls
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