Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Nystatin and Triamcinolone Acetonide Cream Recalled by Taro Pharmaceuticals U.S.A., Inc. Due to Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month...

Date: March 28, 2017
Company: Taro Pharmaceuticals U.S.A., Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Taro Pharmaceuticals U.S.A., Inc. directly.

Affected Products

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

Quantity: 278,304 tubes

Why Was This Recalled?

Failed Content Uniformity Specifications; out-of-specification (OOS) results 18-month stability

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Taro Pharmaceuticals U.S.A., Inc.

Taro Pharmaceuticals U.S.A., Inc. has 36 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report