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Class IIDrug recallOngoing

Lidocaine Ointment USP recall

Recalled by Preferred Pharmaceuticals, Inc. of Anaheim, CA · FDA report 10/14/2026

Not an official recall notice and may be delayed. Confirm with the manufacturer or the agency.

Class
Class II
Moderate
Status
Ongoing
Recall started
09/28/2026
Distribution
Nationwide

Reason for recall

Failed Content Uniformity Specifications

Class II: Use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.

Recalled product

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
Lot and 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.
Recall number
D-0013-2027
Event ID
99994
Initiated by
Voluntary: Firm initiated

Where it was distributed

USA Nationwide

  • Nationwide

Recall timeline

  1. 09/28/2026Firm started the recall
  2. 10/06/2026FDA classified it as Class II
  3. 10/14/2026Published in the FDA enforcement report

More recalls from Preferred Pharmaceuticals

Frequently asked questions

Why was Lidocaine Ointment USP recalled?
Failed Content Uniformity Specifications
What does Class II mean?
Class II is FDA's moderate recall category: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
Where was the recalled product sold?
USA Nationwide
Is this recall still active?
The FDA lists the recall as ongoing. The recall is still in progress.

Source: U.S. Food and Drug Administration, openFDA enforcement report · Last updated 10/14/2026 · Do not rely on openFDA to make decisions regarding medical care