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Moderate riskFDA DrugClass III

Sun Pharmaceutical clindamycin topical solution recalled for impurity and potency issues

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.

From the FDA notice · Read the official notice ↗ · All Sun Pharmaceutical recalls

What to do

  1. Check your clindamycin bottle for lot numbers AD30154, AD31143, or AD31145 with expiration date 11/30/2025
  2. Stop using the medication if you have one of these lots
  3. Contact your pharmacy or doctor for a replacement prescription
  4. Do not flush or throw the medication in the trash; ask your pharmacy how to safely dispose of it
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Illnesses reported
None reported
Manufactured in
2 Independence Way, Princeton, NJ, United States
Classification
Class III
Recall number
D-0257-2026

In the FDA's words

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 Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025 Distribution: Nationwide in the USA.
Hazard
Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay.

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