Sun Pharma Recalls Lidocaine Ointment, Nystatin Cream in US Over Quality Issues
New Delhi: Sun Pharmaceutical Industries has initiated voluntary recalls of Lidocaine Ointment USP, 5%, and Nystatin Cream USP in the United States following quality-related issues identified during testing, according to the US Food and Drug Administration (FDA) recall information.
The company is recalling 65,328 jars of Lidocaine Ointment USP, 5%, Spearmint Flavor, supplied in 50 g jars as a prescription-only product. The ointment is manufactured by Taro Pharmaceuticals Inc., Brampton, Ontario, Canada, and distributed in the US by Taro Pharmaceuticals U.S.A. Inc., Hawthorne, New York.
The affected product carries NDC 51672-3008-5 and belongs to Lot AD48154, with an expiration date of April 30, 2027.
The Lidocaine recall was initiated after the product failed to meet content uniformity specifications. According to the FDA recall information, the product was found to be out of specification for assay during analysis at the 24-month long-term stability station under storage conditions of 25°C and 60% relative humidity.
The recall is listed under D-0848-2026 and Event ID 99794 and has been classified as a Class II recall. The voluntary recall was initiated by the firm on August 31, 2026, while the FDA centre classification date was September 15, 2026. The recall covers nationwide distribution across the US.
A Class II recall refers to a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, while the probability of serious adverse health consequences is considered remote.
Separately, Sun Pharma is recalling an undisclosed quantity of Nystatin Cream USP, a prescription-only antifungal product supplied in 15 g tubes, after the product failed to meet stability specifications.
The Nystatin Cream is manufactured by Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel, and distributed in the US by Taro Pharmaceuticals U.S.A. Inc., Hawthorne, New York. The product carries NDC 51672-1289-1.
The recall involves Lot AD49605 and Lot AD49606, both carrying an expiration date of May 31, 2027. The recall is identified as D-0872-2026 under Event ID 99876 and has an updated Class II classification.
The Nystatin recall was voluntarily initiated by the firm on September 14, 2026, while the FDA centre classification date was September 25, 2026. The distribution pattern covers the US nationwide.
The two recalls involve different Taro manufacturing facilities and separate recall numbers. The Lidocaine Ointment recall concerns an assay and content uniformity issue, while the Nystatin Cream recall relates to a failure of stability specifications. ETPharma also reported the recalls based on the FDA's latest enforcement report.
Lidocaine is a local anaesthetic used to temporarily numb an area and reduce pain by blocking pain signals from nerves, while Nystatin is an antifungal medicine used to treat fungal infections. Both products are prescription-only drugs.
