Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hydrocodone Bitartrate and Acetaminophen Oral Solution Recalled by VistaPharm, Inc. Due to CGMP Deviations: Purified water used to manufacture the...
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 VistaPharm, Inc. directly.
Affected Products
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Quantity: 32,027 bottles and 16,310 unit dose cups
Why Was This Recalled?
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About VistaPharm, Inc.
VistaPharm, Inc. has 32 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report