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Class II · ModerateActive recall

Lidocaine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot # AD48154, Exp: 4/30/2027.
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySun Pharmaceutical Industries, Inc.
Brand nameLIDOCAINE
Generic nameLIDOCAINE
Active ingredient(s)LIDOCAINE
Distributed by / forSUN PHARMA /TARO
NDC51672-3008-5
Show the full FDA record
Full product labelLidocaine 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
Recalling firmSUN PHARMA /TARO
DistributionNationwide in the USA
Quantity65,328 50g jars
Recall initiated2026-08-31
Report date2026-09-23
Recall completed—
Recall numberD-0848-2026
ClassificationClass II
FDA statusOngoing
Origin on fileHawthorne NY United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.