Oxycodone Hydrochloride Tablets Recalled for Out-of-Specification Impurity
Lupin Pharmaceuticals is recalling Oxycodone Hydrochloride Tablets (5 mg) due to out-of-specification impurity test results detected during long-term stability testing. Affected units were distributed in New York and Ohio.
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 FDA classified this recall as Class III, which corresponds to a lower severity. The source text reports an out-of-specification impurity detected during stability testing with no reported illnesses or injuries, making this a precautionary recall grounded in a quality control finding rather than an actual safety event.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100-count bottles (NDC 43386-432-01) because an out-of-specification impurity was observed at the 18-month long-term stability time point during product testing.
The recalled product includes Lot # S000268 with an expiration date of January 2022. Approximately 23,965 100-count bottles were distributed in New York and Ohio.
Consumers and healthcare providers in the affected states with this product should cease use and contact Lupin Pharmaceuticals or consult their healthcare provider with questions. The product is prescription-only and was manufactured by Novel Laboratories, Inc. in Somerset, New Jersey for Lupin Pharmaceuticals, Inc. in Baltimore, Maryland.
The recalled product
- Product
- OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
- Brand
- OXYCODONE HYDROCHLORIDE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Opioid
- Hazard
- out-of-specification-impurity
- quality-control-failure
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 # S000268
- Exp. date January 2022
UPCs (12)
- 0343386434015
- 0343386434039
- 0343386430031
- 0343386432059
- 0343386431052
- 0343386430017
- 0343386433032
- 0343386433018
- 0343386431038
- 0343386432011
- 0343386432035
- 0343386431014
Distribution
Distributed in 2 states:
- NY
- OH
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