FDAFDA recall D-0848-2026 · Sep 23, 2026
SUN PHARMA /TARO: Lidocaine Ointment USP recall
Recall found
Product
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
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).
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lot # AD48154, Exp: 4/30/2027.
- Quantity
- 65,328 50g jars
- Distribution
- Nationwide in the USA
- Recalling firm
- SUN PHARMA /TARO, Hawthorne, NY
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-31
Source: openFDA enforcement record D-0848-2026 · search recall number D-0848-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.