Lidocaine Ointment
FDA Recall NDC 51672-3008
Latest: Class II · Status: Ongoing · Initiated Aug 31, 2026 · 1 enforcement report
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Lidocaine (NDC 51672-3008). A significant event, classified as Class II, was initiated on Aug 31, 2026 by Sun Pharmaceutical Industries, Inc.. The reported reason for this action was: "Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH)."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
August 2026 Class II 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).
Recall Number
Class II Ongoing
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
Aug 31, 2026
Sep 23, 2026
65,328 50g jars
Recall Profile & Regulatory Data
Event ID
99794
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SUN PHARMA /TARO
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# AD48154, Exp: 4/30/2027.
Affected Packages Involved in this Recall
51672-3008-5Lidocaine
51672-3008-3Lidocaine
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
