Checked
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
- 09/28/2026Firm started the recall
- 10/06/2026FDA classified it as Class II
- 10/14/2026Published in the FDA enforcement report
More recalls from Preferred Pharmaceuticals
- Class IIDrugOngoing04/15/2026Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5...Preferred Pharmaceuticals, Inc. · Lack of Assurance of Sterility
- Class IIDrugOngoing12/24/2025Ondansetron ODT Tablets, USP 4mg, 1x10 unit dose tablets, Mfg: Glenmark Pharmaceuticals Limited...Preferred Pharmaceuticals, Inc. · Defective container: Preferred Pharmaceuticals received a letter...
- Class IIDrugOngoing05/07/2025Clindamycin Hydrochloride Capsules, USP, 300mg, 30-count bottles, Manufactured by: Glenmark...Preferred Pharmaceuticals, Inc. · cGMP Deviations
- Class IIDrugOngoing09/04/2024Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's...Preferred Pharmaceuticals, Inc. · Failed Impurities/Degradation Specifications - at 18-month...
- Class IIDrugOngoing05/29/2024Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC...Preferred Pharmaceuticals, Inc. · CGMP Deviations: Presence of N-nitroso-duloxetine impurity above...
- Class IIDrugOngoing07/12/2023Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count...Preferred Pharmaceuticals, Inc. · Failed Stability Specifications
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