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FDA · Drugs ·

Lidocaine Ointment USP, 5%, Speermint Flavor recall

SUN PHARMA /TARO recalled Lidocaine Ointment USP, 5%, Speermint Flavor on September 23, 2026 because of failed content uniformity specifications. It was sold nationwide.

Why it was recalled

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

What's recalled

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

Quantity: 65,328 50g jars

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
SUN PHARMA /TARO, Hawthorne, NY
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
Nationwide
Nationwide in the USA
Status
Ongoing
Recall number
D-0848-2026
Source
U.S. Food and Drug Administration

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