FlaggedRx← Medication recall checkHome
Class III · Lower riskRecall completed

Oxycodone Hydrochloride

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot # S000268, Exp. date January 2022
Where it was soldProduct Distributed in NY and OH.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Out-of-specification impurity test result observed at 18-month long term stability time point.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byNovel Laboratories, Inc. Somerset, NJ 08873
Brand nameOXYCODONE HYDROCHLORIDE
Generic nameOXYCODONE HYDROCHLORIDE
Active ingredient(s)OXYCODONE HYDROCHLORIDE
Distributed by / forLupin Pharmaceuticals, Inc. Baltimore, MD 21202
NDC43386-432-01
Show the full FDA record
Full product labelOxycodone 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
Recalling firmLupin Pharmaceuticals Inc.
DistributionProduct Distributed in NY and OH.
Quantity23,965 100 count bottles
Recall initiated2021-12-29
Report date2022-01-12
Recall completed2022-08-23
Recall numberD-0358-2022
ClassificationClass III
FDA statusTerminated
Origin on fileBaltimore MD United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.