Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx only, Mfg: Taro Pharmaceuticals U.S.A., I
Summary
The FDA issued a Class II for Lidocaine Ointment USP, 5% (Generic for Xylocaine), packaged in a 50 g jar, Rx o by Preferred Pharmaceuticals, Inc.. Reason: Failed Content Uniformity Specifications.
Details
Source
Drug Recall
External ID
D-0013-2027
Action Date
2026-10-14
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot #: F1925G, Expiry: 4/30/2027; Lot #: E0925T, Expiry: 4/30/2027; Lot # D3025M, Expiry: 4/30/2027; Lot #: D0825D, Expiry: 4/30/2027.
Quantity Affected: N/A
Reason for Recall
Failed Content Uniformity Specifications
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-28
Company
Anaheim, CA
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 67 drug-related FDA actions this month.
Preferred Pharmaceuticals, Inc. has 37 FDA actions in our database, including 37 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Preferred Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Preferred Pharmaceuticals, Inc. have FDA actions?
Preferred Pharmaceuticals, Inc. has 37 FDA actions in our database, including 37 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0013-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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