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D-0848-2026Class II

SUN PHARMA /TARO

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
SUN PHARMA /TARO
Product type
Drug
Status
Ongoing
Report date
2026-09-23
Distribution
Nationwide in the USA
Firm state
NY
Product quantity
65,328 50g jars
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

Product description

Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro Pharmaceuticals U.S.A. Inc. Hawthorne NY 70532 NDC: 51672-3008-5

Code / lot info

Lot # AD48154, Exp: 4/30/2027.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →