Nystatin Triamcinolone Cream (Taro) – content uniformity (2017)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone acetonide, distributed in a) 15 grams (NDC 51672-1263-1), b) 30 grams (NDC 51672-1263-2) and c) 60 grams (NDC 51672-1263-3) tubes, Rx only, TARO label; Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1 -- Dist. by: Taro Pharmaceuticals U.S.A. Inc., Hawthorne, NY 10532
Brand
Taro Pharmaceuticals U.S.A., Inc.
Lot Codes / Batch Numbers
a) 15 g: Lot B505118501, exp. date January 2018, b) 30 g: Lot B504918500, exp. date January 2018, c) 60 g: Lots: I416616979, exp. date August 2017, I416716979, exp. date August 2017 and D504519119, exp. date March 2018
Products Sold
a) 15 g: Lot B505118501, exp. date January 2018; b) 30 g: Lot B504918500, exp. date January 2018; c) 60 g: Lots: I416616979, exp. date August 2017, I416716979, exp. date August 2017 and D504519119, exp. date March 2018
Taro Pharmaceuticals U.S.A., Inc. is recalling Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 USP nystatin units and 1 mg triamcinolone a due to Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026