FDA Recall D-0257-2026

SUN PHARMACEUTICAL INDUSTRIES INC · Princeton, NJ

Class III Ongoing 169 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

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

Reason for recall

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

Recall record

Recall number: D-0257-2026
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA.
Recall initiated: 2025-11-26
Classified by FDA Center: 2026-01-14
FDA published: 2026-01-21
Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC
Firm location: Princeton, NJ

Drug identification

Brand name(s): CLINDAMYCIN PHOSPHATE
Generic name(s): CLINDAMYCIN PHOSPHATE
Manufacturer(s): Sun Pharmaceutical Industries, Inc.
NDC(s): 51672-4081
Route(s): TOPICAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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