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CLASS II · ModerateFDA

SUN PHARMA /TARO recalls Lidocaine Ointment USP

📅 Aug 31, 2026 · 📍 Nationwide
Recalling company
SUN PHARMA /TARO
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
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Aug 31, 2026
Reported
Sep 23, 2026
Distribution
Nationwide in the USA
Status
Ongoing
Quantity
65,328 50g jars
Lot / codes
Lot # AD48154, Exp: 4/30/2027.
Company location
Hawthorne, NY
Recall type
Voluntary: Firm initiated
Recall number
D-0848-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0848-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.