D-0848-2026 Class II Ongoing
FDA drug recall D-0848-2026 was initiated by SUN PHARMA /TARO on August 31, 2026 and is designated Class II. 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). The recall status is ongoing. Affected quantity: 65,328 50g jars.
Recall Details
- Product Type
- Drugs
- Report Date
- September 23, 2026
- Initiation Date
- August 31, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 65,328 50g jars
Product Description
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).
Distribution Pattern
Nationwide in the USA
Code Information
Lot # AD48154, Exp: 4/30/2027.