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.
What this means for you
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.
See all 2 products in this recall →Related recalls
Same manufacturer · Pfizer Inc.
See all →- HighSodium bicarbonate injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighEpinephrine injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighBicillin L-A 2.4 million unit vials recalled after particulates found
FDA (Drugs) · 2025-08-06
- HighBicillin L-A penicillin vials recalled after particulates found during visual inspection
FDA (Drugs) · 2025-08-06
- ModerateDobutamine Injection Recall Due to Discoloration and Cracked Vials
FDA (Drugs) · 2025-07-02
Same hazard · impurities
See all →- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateGlycopyrrolate Oral Solution Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-29
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMethohexital Sodium 100 mg/10 mL Compounded Drug Recalled Nationwide
FDA (Drugs) · 2026-07-15
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08