Lupin Pharmaceuticals recalls 5mg oxycodone tablets due to impurity detected at 18-month stability test. This may pose safety risks if stored beyond expiration.
Out-of-specification impurity test result observed at 18-month long term stability time point.
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.
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.
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.
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.
Verify the NDC code 43386-432-01 and lot number S000268 on the product label.
The recall indicates an impurity detected at 18 months of storage, but the product is still safe to use within its expiration date.
Look for the NDC code 43386-432-01 and lot number S000268 on the product label.
The recall does not specify a remedy, so check with your healthcare provider for guidance.
We’ve drafted a message you can send Lupin Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0358-2022 — Lupin Pharmaceuticals Lupin Pharmaceuticals Hello, I own a Lupin Pharmaceuticals that is covered by recall D-0358-2022 from Lupin Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
