FDA-Drug2026-09-23Class IICHEMICAL
Taro Lidocaine Ointment 5% recalled for failed strength specifications
What this means
Taro Pharmaceuticals is recalling one lot of Lidocaine Ointment USP 5% because testing found the active ingredient strength was outside acceptable limits. The affected lot was identified during long-term stability testing. No injuries have been reported.
- Check if you have lot #AD48154 with expiration date 4/30/2027
- Do not use this ointment; contact your pharmacy or healthcare provider for a replacement
- Return the product to your pharmacy
The agency's original wording
Hazard
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
65,328 50g jars
Manufactured in
3 Skyline Dr, N/A, Hawthorne, NY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0848-2026Want us to check the next one for you?
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