CLASS III ONGOING Drug recall · Reported 15 Nov 2023 · FDA Enforcement Report
Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg recalled
Zyla Life Sciences US is recalling Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg per, distributed nationwide in the US. The recall was initiated on 20 Oct 2023 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0094-2024
- FDA event ID
- 93254
- Recalling firm
- Zyla Life Sciences US, Lake Forest, IL
- Brand
- Oxaydo
- Manufacturer
- Zyla Life Sciences US LLC
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 20 Oct 2023
- FDA classified
- 8 Nov 2023
- Reported
- 15 Nov 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 20 Oct 2023 | Recall initiated by company | |
| 8 Nov 2023 | Classified by FDA | +19 days |
| 15 Nov 2023 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Sub-potent Drug: Lower potency than labeled.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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 was distributed
Nationwide
Questions about this recall
Why was it recalled?
Sub-potent Drug: Lower potency than labeled.
Which lots are affected?
Lot 22W02, Exp 01/31/2025
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Oxycodone recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg recalledOxycodone And Acetaminophen | SpecGx | Other | Nationwide |
| Drug | CLASS II | Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg recalledOxycodone And Acetaminophen | SpecGx | Other | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Oxycodone Hydrochloride Oral Solution, USP 5 mg per (1 mg/mL) recalled | Akorn | Labeling Errors | Nationwide |