VistaPharm Recalls Hydrocodone and Acetaminophen Oral Solution Due to Labeling Error
VistaPharm, Inc. is recalling 3,084 bottles of Hydrocodone Bitartrate and Acetaminophen Oral Solution because the product was incorrectly labeled as a Class III controlled substance instead of a Class II controlled substance.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The issue is a documentation and labeling error regarding the controlled substance classification, not a physical defect or contamination.
Plain-English summary
VistaPharm, Inc. is recalling 3,084 bottles of Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles. The product is prescription-only and was manufactured by VistaPharm, Inc. in Largo, FL. The specific lot number is 494700, with an expiration date of 10/2018.
The recall was initiated due to a labeling error. The product was incorrectly labeled as a Class III controlled substance instead of a Class II controlled substance. This classification error affects the regulatory status of the medication as defined by federal law.
The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific NDC (66689-023-16) and lot number. If found, the product should be returned to the pharmacy or healthcare provider for disposal or replacement in accordance with local regulations.
The recalled product
- Product
- Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL (Cherry Flavored), 473 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771 ---- NDC 66689-023-16
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Controlled Substance
- Hazard
- Affected units
- 3,084
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 494700 Exp. 10/2018
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · VistaPharm, Inc.
See all →- ModeratePrescription pyridostigmine bromide oral solution recalled for out-of-specification preservative
FDA (Drugs) · 2022-11-02
- ModerateClobazam Oral Suspension Recalled for Failed Stability Specifications
FDA (Drugs) · 2022-01-26
- LowVistaPharm Recalls Nystatin Oral Suspension Due to Impurity
FDA (Drugs) · 2020-10-14
- LowVistaPharm Recalls Nystatin Oral Suspension Due to Impurity Peak
FDA (Drugs) · 2020-07-15
- LowVistaPharm Recalls Nystatin Oral Suspension Due to Impurity Exceeding Specifications
FDA (Drugs) · 2020-07-15
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
Similar recalls
- SevereVistaPharm Recalls Hydrocodone and Acetaminophen Oral Solution Due to Impurities
FDA (Drugs) · 2012-07-18
- SevereVistaPharm Recalls Hydrocodone and Acetaminophen Oral Solution Due to Contamination
FDA (Drugs) · 2017-02-08
- LowVistaPharm Recalls Metoclopramide Oral Solution Due to Labeling Error
FDA (Drugs) · 2012-09-05
- ModerateMallinckrodt Recalls Hydrocodone and Acetaminophen Oral Solution Due to Expired Flavoring
FDA (Drugs) · 2012-08-08
- ModerateVistaPharm Recalls Aminocaproic Acid Oral Solution Due to High Ethylene Glycol
FDA (Drugs) · 2023-12-06
- SevereVistaPharm Recalls Oxycodone Hydrochloride Oral Solution Due to Water Contamination
FDA (Drugs) · 2017-02-08