OXYCODONE HYDROCHLORIDE

Generic: OXYCODONE HYDROCHLORIDE

Epic PharmaManufacturer

ORALRoute

OXYCODONE HYDROCHLORIDEActive Substance

2015-09-22Original Approval

OXYCODONE HYDROCHLORIDE is FDA application ANDA202662, sponsored by EPIC PHARMA LLC. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2026-01-14

Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug prod

Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out

Class III2018-01-22

Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., P

Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol

Class III2016-05-19

Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH ---

Failed Impurities/Degradation Specification; 9 month stability

Class III2021-12-29

Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, In

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

Class II2022-02-22

Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Ins

Impurity failure at 0-time of the repackaged lot.

Class III2020-12-23

Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Ca

Presence of Foreign Substance: Particulate matter was found in multiple lots of product.

Class II2021-08-19

Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coven

Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 w

OXYCODONE HYDROCHLORIDE

Recalls

Top Reported Reactions