VistaPharm Recalls Oxycodone Hydrochloride Oral Solution Due to Defective Container Seals
VistaPharm is recalling 8,901 cases of Oxycodone Hydrochloride Oral Solution because defective container seals may allow the medication to leak.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a reasonable probability of temporary or medically reversible health consequences, fitting the Moderate severity criteria for minor defects or low-risk contamination.
Plain-English summary
VistaPharm, Inc. is recalling 8,901 cases of Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml). The affected product is identified by Lot # 435200 and an expiration date of 01/18. The medication is packaged in 10 unit dose cups per tray, with 5 trays per case, and is distributed nationwide.
The recall was initiated due to a defective container issue. Excess lidding material has accumulated between the seal and the cup, preventing the lid from adhering properly. This defect allows the liquid medication to leak from the unit dose cups.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for instructions on how to return or dispose of the medication. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-01), shrink- wrapped in 10 unit dose cups x 5 trays per case (NDC 66689-401-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
- Manufacturer
- VistaPharm, Inc.
- Category
- Drug — Oral Solution
- Affected units
- 8,901
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 (2)
- Lot # 435200
- EXP 01/18
Distribution
Distributed nationwide across the United States.
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