Recall archive / FDA drug enforcement
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals,... — FDA record D-0358-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 29, 2021. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01
- Reason
- Out-of-specification impurity test result observed at 18-month long term stability time point.
- Classification
- Class III
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Quantity
- 23,965 100 count bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0358-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # S000268, Exp. date January 2022 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Product Distributed in NY and OH.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Jan 12, 2022
- Recall initiation date
- Dec 29, 2021
- Center classification date
- Jan 5, 2022
- Termination date
- Aug 23, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.