Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Fluconazole Oral Suspension Recalled by Teva Pharmaceuticals USA, Inc. Due to Failed Stability Specifications: this product is below specification...
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 Teva Pharmaceuticals USA, Inc. directly.
Affected Products
Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95.
Quantity: 234,242 bottles
Why Was This Recalled?
Failed Stability Specifications: this product is below specification for preservative content.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Teva Pharmaceuticals USA, Inc.
Teva Pharmaceuticals USA, Inc. has 33 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report