Taro recalls Lidocaine Ointment 5% 50 g jars over failed strength test
During 24-month stability testing, the ointment failed the test for how evenly the active ingredient is mixed, so the strength of the medicine in the jars may not be what the label says.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- 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
- Company
- Sun Pharma /Taro
- 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).
- Units
- 65,328 50g jars
- Where sold
- Nationwide in the USA
- FDA classification
- Class II · Ongoing
- Classified by FDA
- September 15, 2026
- Recall started
- August 31, 2026
- FDA enforcement report
- September 23, 2026
- Identifiers
- Codes: Lot # AD48154, Exp: 4/30/2027.
- FDA recall number: D-0848-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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).
- Classification
- Class II (Ongoing)
- Distribution
- Nationwide in the USA
- Quantity
- 65,328 50g jars
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