Class II · Moderate risk
Oxycodone Hydrochloride Tablets
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Oxaydo (oxycodone HCl, USP) (Oxycodone Hydrochloride)
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Sub-potent Drug: Lower potency than labeled.
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
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
Affected NDC
69344-0213-11
Compare with the code on your package — it is the most precise check available.
Drug: Oxycodone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Oxaydo Oxycodone Hydrochloride NDC 69344-0213 |
7.5 mg/1 | Tablet Oral |
Zyla Life Sciences US LLC | Rx · CII |
- Recalling firm
- Zyla Life Sciences US Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0094-2024 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Oxycodone recalls
See all
Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk
Oxycodone and Acetaminophen CII Tablets USP
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
Impurity failure at 0-time of the repackaged lot.
Class III · Low risk
Oxycodone Hydrochloride Tablets
Out-of-specification impurity test result observed at 18-month long term stability time point.
Other wrong potency / content recalls from 2023
All wrong potency / content recalls
Class I · High risk
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
Class I · High risk
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride
Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose of drug product to IV bags.
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