CLASS III Drug recall · Reported 12 Jan 2022 · FDA Enforcement Report
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg recalled
Lupin Pharmaceuticals is recalling Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, distributed in New York, Ohio. The recall was initiated on 29 Dec 2021 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0358-2022
- FDA event ID
- 89324
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Dec 2021
- FDA classified
- 5 Jan 2022
- Reported
- 12 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 29 Dec 2021 | Recall initiated by company | |
| 5 Jan 2022 | Classified by FDA | +7 days |
| 12 Jan 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out-of-specification impurity test result observed at 18-month long term stability time point.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Product Distributed in NY and OH.
Questions about this recall
Is Oxycodone Hydrochloride Tablets, USP C-II, 5 mg recalled?
Yes. Lupin Pharmaceuticals recalled Oxycodone Hydrochloride Tablets, USP C-II, 5 mg on 29 Dec 2021. The recall is Class III and its status is Terminated. Recall number D-0358-2022.
Why was it recalled?
Out-of-specification impurity test result observed at 18-month long term stability time point.
Which lots are affected?
Lot # S000268, Exp. date January 2022
Where was it sold?
Product Distributed in NY and OH.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Lupin Pharmaceuticals
All 123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Lupin Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Glucagon Emergency Kit for Low Blood Sugar, Glucagon recalledGlucagon | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide | Lupin Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride | Lupin Pharmaceuticals | Packaging Defects | Nationwide |
Other Oxycodone recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Oxaydo (oxycodone HCl, USP) tablets, 5 mg recalledOxaydo | Zyla Life Sciences US | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Oxycodone Hydrochloride Oral Solution, USP 5 mg per (1 mg/mL) recalled | Akorn | Labeling Errors | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP, 10 mg recalledOxycodone Hydrochloride | Rhodes Pharmaceuticals | Other | Nationwide |