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).
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
Lot numbers, UPCs & expiration codes
Lot # AD48154, Exp: 4/30/2027.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0848-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Aug 31, 2026
- FDA report date
- Sep 23, 2026
- Quantity
- 65,328 50g jars
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMA /TARO
Original FDA data
Every field from FDA enforcement report D-0848-2026, exactly as published.
Show all FDA fields
- City
- Hawthorne
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 99794
- Address
- 3 Skyline Dr
- Code information
- Lot # AD48154, Exp: 4/30/2027.
- Postal code
- 10532-2174
- Report date
- Sep 23, 2026
- Product type
- Drugs
- Recall number
- D-0848-2026
- Classification
- Class II
- Recalling firm
- SUN PHARMA /TARO
- Product quantity
- 65,328 50g jars
- 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).
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Aug 31, 2026
- Initial firm notification
- Letter
- Center classification date
- Sep 15, 2026