Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario,
Summary
The FDA issued a Class II for Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd. by: Taro P by SUN PHARMA /TARO. Reason: Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Details
Source
Drug Recall
External ID
D-0848-2026
Action Date
2026-09-23
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot # AD48154, Exp: 4/30/2027.
Quantity Affected: 65,328 50g jars
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).
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-31
Company
Hawthorne, NY
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 17 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
SUN PHARMA /TARO has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SUN PHARMA /TARO) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SUN PHARMA /TARO have FDA actions?
SUN PHARMA /TARO has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0848-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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