Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fluorouracil Topical Cream USP Recalled by Taro Pharmaceuticals U.S.A., Inc. Due to Product Lacks Stability: Out-of-specification (OOS) results were observed...
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
Fluorouracil Topical Cream USP, 5%, 40 g Tube, Rx only, Mfd. by: Taro Pharmaceutical Industries, Ltd. Haifa Bay, Israel 26110, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4118-6.
Quantity: 39,982 Tubes
Why Was This Recalled?
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Taro Pharmaceuticals U.S.A., Inc.
Taro Pharmaceuticals U.S.A., Inc. has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report