Pfizer Recalls Oxecta Tablets Due to Failed Impurity Specifications
Pfizer is recalling 137 bottles of Oxecta (oxycodone HCl) 5 mg tablets because they failed impurity and degradation specifications.
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 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 III, which indicates a low probability of adverse health consequences, aligning with the Moderate severity level for minor specification failures without reported injuries.
Plain-English summary
Pfizer Inc. is recalling 137 bottles of Oxecta (oxycodone HCl) tablets, 5 mg, 100 count bottles. The product is prescription-only and was manufactured and distributed by King Pharmaceuticals, Inc. in Bristol, TN. The specific lot affected is 13T02 with an expiration date of 12/15.
The recall was initiated because the product failed impurities and degradation specifications. The distribution pattern for these units was nationwide.
Consumers should check their medication for the NDC 60793-525-01 and Lot 13T02. If they possess this specific product, they should contact their healthcare provider or pharmacist for guidance on disposal or replacement.
The recalled product
- Product
- Oxecta(TM) (oxycodone HCl) tablets, 5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-525-01
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 137
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 13T02
- Exp. 12/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Pfizer Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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