Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Nystatin Oral Suspension Recalled by Akorn, Inc. Due to Failed Impurities/Degradation Specifications: Out of Specification for an...
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 Akorn, Inc. directly.
Affected Products
Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16
Quantity: 2,796 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.
Where Was This Sold?
This product was distributed to 2 states: AR, MS
About Akorn, Inc.
Akorn, Inc. has 176 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report