FDAClass IIIJanuary 21, 2026

Clindamycin Phosphate USP recall: Impurity Out of Spec

Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa…

Why was Clindamycin Phosphate USP recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot#: AD30154, AD31143, AD31145, Exp 11/30/2025

Product
Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applicator bottle, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa…
Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Distribution
Nationwide in the USA.
Recall date
January 21, 2026
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls