# FDA recall D-0848-2026

> **SUN PHARMA /TARO** · Class II · drug recall initiated 2026-08-31.

## 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 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).

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0848-2026
- **Recalling firm:** SUN PHARMA /TARO
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-08-31
- **Report date:** 2026-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Hawthorne, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0848-2026

## Citation

> MORVS. FDA recall D-0848-2026. Retrieved 2026-10-20 from https://api.morvs.ai/recall/D-0848-2026. Source: US FDA. Licensed CC0.

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