August 2026 FDA Recall Lidocaine by Sun Pharma /taro (D-0848-2026 - 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 Class II drug recall was voluntarily initiated by Sun Pharma /taro on August 31, 2026 for the product Lidocaine. The FDA reported the reason for recall as failed content uniformity specifications. out of specification for assay during analysis at the 24- month long term stability station, at (25¿c,60%rh).. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0848-2026

Reason for 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).
Initiated
08-31-2026
Reported
09-23-2026
Quantity
65,328 50g jars

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99794
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMA /TARO
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
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

51672-3008-5 Lidocaine
51672-3008-3 Lidocaine