FDAClass IISeptember 23, 2026

Lidocaine Ointment USP recall

Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro…

Why was Lidocaine Ointment USP 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 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 # AD48154, Exp: 4/30/2027.

Product
Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, L6T1C, Canada, Dist By: Taro…
Recalling firm
SUN PHARMA /TARO
Quantity
65,328 50g jars
Distribution
Nationwide in the USA
Recall date
September 23, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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