Pfizer Recalls Oxecta Tablets Due to Failed Impurity Specifications
Pfizer is recalling 139 bottles of Oxecta (oxycodone HCl) 7.5 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 the rubric associates with scores of 1 or 2. A score of 2 is assigned as it involves a pharmaceutical product failing quality specifications, which is more significant than a cosmetic defect but unlikely to cause adverse health consequences.
Plain-English summary
Pfizer Inc. is recalling 139 bottles of Oxecta (oxycodone HCl) tablets, 7.5 mg, 100 count bottles. The specific lot affected is 13T03 with an expiration date of 12/15. The product is a prescription-only medication manufactured and distributed by King Pharmaceuticals, Inc. in Bristol, TN.
The recall was initiated because the product failed impurities and degradation specifications. The agency has classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences.
The affected product was distributed nationwide. Consumers and healthcare providers should discontinue use of the recalled lot and return the product to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- Oxecta(TM) (oxycodone HCl) tablets, 7.5 mg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc. Bristol, TN, NDC 60793-526-01
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 139
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 13T03
- 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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