FDA Drugs recall ·
Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd recall
- Recall number
- D-0848-2026
- Date
- (initiated August 31, 2026)
- Company / brand
- Sun Pharma /Taro
3 Skyline Dr, Hawthorne, NY, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 65,328 50g jars
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot # AD48154, Exp: 4/30/2027.
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0848-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.