Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nystatin Cream Recalled by Crown Laboratories Due to Subpotent Drug: Out of specification for assay at...
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 Crown Laboratories directly.
Affected Products
Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured and Distributed by: Crown Laboratories, Inc. Johnson City, TN 37604, NDC 0316-0221-15
Quantity: 35,931 tubes
Why Was This Recalled?
Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Crown Laboratories
Crown Laboratories has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report