Elevated site urgencyFDA Class II

Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd

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

Agency
FDA Drug
Recall date
Aug 31, 2026
Status
Ongoing
Company
SUN PHARMA /TARO

1. What product was recalled?

Lidocaine Ointment USP, 5%, Speermint Flavor, 50 g Jar, Rx only, Mfd

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

Quantity: 65,328 50g jars

Code or lot text: Lot # AD48154, Exp: 4/30/2027.

LOT
Exp: 4/30/2027.
LOT
Lot # AD48154
NDC
51672-3008
NDC
51672-3008-3
NDC
51672-3008-5
RECALL-NUMBER
D-0848-2026

2. Is my exact product affected?

Compare every printed identifier. A matching value can indicate that your product is included.

3. What is the hazard?

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

4. What should I do now?

Follow the FDA recall notice and contact the recalling company for current instructions.

5. Where was it sold or distributed?

Nationwide

6. Were injuries or illnesses reported?

No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.

7. What remedy is available?

Follow the FDA recall notice and contact the recalling company for current instructions.

8. Is the recall active or closed?

The source status is Ongoing. The Recall Guy's urgency label is elevated, which is a separate deterministic site label.

9. When was the information checked?

Last checked .

  1. created

10. Where is the official source?

Open the official FDA Drug source

The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.