Lupin Oxycodone Tablets Recall: Impurity Risk in Long-Term Storage
Lupin Pharmaceuticals recalls 5mg oxycodone tablets due to impurity detected at 18-month stability test. This may pose safety risks if stored beyond expiration.
Lower-risk recall
Out-of-specification impurity test result observed at 18-month long term stability time point.
Contact the company
What happened, in plain English
Lupin Pharmaceuticals is recalling 5mg oxycodone hydrochloride tablets that tested positive for an impurity after 18 months of storage. This could create safety risks if the tablets are used after the expiration date. Read more at govinfonow.com/recall/35413-lupin-oxycodone-tablets-recall-impurity-risk-in-long-term-storage.
Source Summary by GovInfoNow · govinfonow.com/recall/35413-lupin-oxycodone-tablets-recall-impurity-risk-in-long-term-storage · Updated August 18, 2026 · FDA enforcement record: FDA #D-0358-2022
Cite this page
“Lupin Oxycodone Tablets Recall: Impurity Risk in Long-Term Storage.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35413-lupin-oxycodone-tablets-recall-impurity-risk-in-long-term-storage. Based on FDA recall #D-0358-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0358-2022%22&limit=1).
Why it’s dangerous
The tablets showed an impurity during a long-term stability test at 18 months. This impurity could potentially cause safety issues if the tablets are used after the expiration date.
Who’s affected
Prescription opioid users who have the 5mg oxycodone tablets with NDC 43386-432-01 and lot number S000268. Patients with valid prescriptions for this medication are most at risk.
How to tell if you have this one
Check for the product name 'Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles' with NDC 43386-432-01 and lot number S000268. These were manufactured by Novel Laboratories, Inc. in Somerset, NJ.
- Brand
Lupin Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Verify the NDC code 43386-432-01 and lot number S000268 on the product label.
Where it went and when
Where it was distributed
Distributed in New York and Ohio.
FDA distribution: “Product Distributed in NY and OH.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: New York, Ohio.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0358-2022 (December 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0358-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.