FDA-Drug2026-01-21Class IIICHEMICAL

Sun Pharmaceutical clindamycin topical solution recalled for impurity and potency issues

OTHERNationwide distribution

Stop using Sun Pharmaceutical clindamycin solution

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
Hazard

Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.

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-0257-2026

More SUN PHARMACEUTICAL INDUSTRIES INC recalls

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief