Taro Lidocaine Ointment
Lidocaine Ointment USP, 5%, Speermint Flavor failed content uniformity specifications and assay specifications.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
SUN PHARMA /TARO, of Hawthorne, New York, recalled Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, manufactured by Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, and distributed by Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY.
The FDA stated the product failed content uniformity specifications and was out of specification for assay during analysis at the 24-month long term stability station, at (25°C, 60%RH). The company began the recall on August 31, 2026, and the FDA added it to its Enforcement Report on September 11, 2026. The product was distributed nationwide in the USA.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your jar affected?
Match the NDC and lot code listed under your product.
Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar
- NDC
- 51672-3008-5
- Lot
- AD48154
Details
- Company began the recall
- Sold in
Nationwide in the USA
- Event ID
- 99794
- Recall No.
- D-0848-2026
- Company
- SUN PHARMA /TAROHawthorne, New York
- Hazard
- Failed specifications
Company began the recall
Added to FDA's Enforcement Report
Listed on Recall Canary
Classified by FDA
In FDA's weekly enforcement report
Summary updated
