Preferred Pharmaceuticals, Inc.: Lidocaine Ointment Usp, 5% (generic For Xylocaine)

Preferred Pharmaceuticals is recalling Lidocaine Ointment USP 5% (a generic version of Xylocaine) in 50-gram jars because the product failed quality testing for consistent active ingredient levels throughout the ointment. The recall affects prescription-only ointment distributed nationwide across all U.S. states and Washington, D.C., manufactured by Taro Pharmaceuticals U.S.A., Inc. This is classified as a Class II recall, meaning the product could cause temporary or reversible health effects.

Recalling firm

Preferred Pharmaceuticals, Inc.

Product

Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., Inc., Prod# (NDC): 68788-7865-05

Reason

Failed Content Uniformity Specifications

Classification

Class II

Category

drug recall

Country

United States

Agency

U.S. Food and Drug Administration

Recall date

2026-09-28

Status

Ongoing

Areas affected

AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...

Distribution

USA Nationwide

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/24e2f16d-8655-4f55-a471-ff677e4404f1