Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit Recalled by CutisPharma, Inc. Due to Labeling: Label error on declared strength. Package Insert...
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 CutisPharma, Inc. directly.
Affected Products
FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05
Quantity: 8,748 kits
Why Was This Recalled?
Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CutisPharma, Inc.
CutisPharma, Inc. 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