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FDA recall 99794: SUN PHARMA /TARO: Lidocaine Ointment USP

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FDARecall 99794Medicines

What to do

The FDA record of this recall has no instruction for consumers. Compare the lot codes below with your product. If they match, do not use it, and follow the notice of the firm or ask the store where you bought it. Talk to your pharmacist or doctor before stopping a medicine.Note from Recalls Watch, not agency text.

Read the official notice on accessdata.fda.gov (opens in a new tab)

Hazard

Why it was recalled

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

FDA classification: Class II. Use may cause temporary or medically reversible health consequences, or the chance of serious consequences is remote. Status: Ongoing.

Is it yours? Products and codes

  • 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

    Lot or code
    Lot # AD48154, Exp: 4/30/2027.
    FDA recall number
    D-0848-2026
    Quantity
    65,328 50g jars

Distribution (FDA): Nationwide in the USA

About this record

Issued by
U.S. Food and Drug Administration
Firm
SUN PHARMA /TARO
Title
Composed by Recalls Watch from fields of the record; FDA records have no title.

If someone was hurt or swallowed something: call 911, or Poison Help at 1-800-222-1222.

About this recall

What is the hazard?

FDA states: “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 should I do if I have this product?

The FDA record of this recall has no instruction for consumers. Compare the lot codes on the notice with your product and follow the notice of the firm. The official report is linked on this page.

How do I know if my product is included?

Compare the lot or code printed on your product with the codes FDA lists on this notice, product by product.

When was this recall published?

FDA published recall 99794 on September 23, 2026.

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