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Oxycodone Hydrochloride
Oxycodone Hydrochloride recalls: 8 FDA reports
Recalls involving Oxycodone Hydrochloride. What was wrong with each batch, and how the FDA graded the risk.
8Reports
0Class I
2Ongoing
2026-02-18Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The
D-0338-2026 · Class II · reported 2026-02-18 · Ongoing
- Why it was recalled
- Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
- Product
- Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11
- Where it went
- Nationwide in the USA
- How much
- 31,676 packages
Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Scienc
D-0094-2024 · Class III · reported 2023-11-15 · Ongoing
- Why it was recalled
- Sub-potent Drug: Lower potency than labeled.
- Product
- Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11
- Where it went
- Nationwide
- How much
- 3,792 bottles
Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Onl
D-0652-2022 · Class II · reported 2022-03-16 · Terminated
- Why it was recalled
- Impurity failure at 0-time of the repackaged lot.
- Product
- Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40
- Where it went
- Nationwide in the USA
- How much
- 89,880 unit-dose cups
Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceu
D-0358-2022 · Class III · reported 2022-01-12 · Terminated
- Why it was recalled
- Out-of-specification impurity test result observed at 18-month long term stability time point.
- Product
- Oxycodone 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
- Where it went
- Product Distributed in NY and OH.
- How much
- 23,965 100 count bottles
Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L
D-0794-2021 · Class II · reported 2021-09-22 · Terminated
- Why it was recalled
- Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
- Product
- Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coventry RI 02816, Manufactured by: Purdue Pharma L.P., Stanford, CT 06901 NDC 42858-002-01
- Where it went
- Product was distributed nationwide.
- How much
- 55,344/100 count bottles
Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950
D-0231-2021 · Class III · reported 2021-01-20 · Terminated
- Why it was recalled
- Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
- Product
- Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, Genus Lifesciences Inc. NDC 64950-354-05 Case NDC: 64950-354-450(40 unit dose cups) Case NDC 64950-354-55 (50 unit dose cups)
- Where it went
- Distributed Nationwide in the USA
- How much
- 1,171,550 cups
Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceutical
D-0248-2018 · Class III · reported 2018-02-07 · Terminated
- Why it was recalled
- Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
- Product
- Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01
- Where it went
- Nationwide
- How much
- 45,875 bottles
Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columb
D-1441-2016 · Class III · reported 2016-07-20 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specification; 9 month stability
- Product
- Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH --- NDC 0054-0390-41
- Where it went
- Nationwide
- How much
- 1,182 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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