Lidocaine Ointment Recall: Sun Pharma TarO Speermint 5% 50 g Jar
FDA recalls Lidocaine Ointment USP, 5%, Speermint flavor, 50 g jar (Rx only) manufactured by TarO Sun Pharma. The recall is due to failed content uniformity specifications and out-of-spec assay at the 24-month long-term stability test at 25°C/60% RH. A total of 65,328 jars distributed nationwide in the USA are included in Lot AD48154, Exp 4/30/2027.
| Brand | SUN PHARMA /TARO |
|---|---|
| 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 |
| Reason | Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH). |
| Severity | moderate |
| Units affected | 65328 |
| Distribution | Nationwide in the USA |
| Agency | FDA |
WHAT YOU SHOULD DO
- If you have Lot AD48154, stop using the product and discard or return it to the place of purchase.
- Check your other products for the same lot number and do not use any that match Lot AD48154.
- If you have used this product and have health concerns, contact your healthcare provider for advice.
How to identify the recalled item
| Lot / date codes | Lot # AD48154, Exp: 4/30/2027. |
|---|---|
| Lot / date codes | Lot # AD48154, Exp: 4/30/2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other SUN PHARMA /TARO recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.