Recalls / Class III
Class IIID-0094-2024
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
- Brand name
- Oxaydo
- Generic name
- Oxycodone Hydrochloride
- Active ingredient
- Oxycodone Hydrochloride
- Route
- Oral
- NDCs
- 69344-113, 69344-213
- FDA application
- NDA202080
- Affected lot / code info
- Lot 22W02, Exp 01/31/2025
Why it was recalled
Sub-potent Drug: Lower potency than labeled.
Recalling firm
- Firm
- Zyla Life Sciences US Inc.
- Manufacturer
- Zyla Life Sciences US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 100 Saunders Rd, Ste 300, Lake Forest, Illinois 60045-2502
Distribution
- Quantity
- 3,792 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2023-10-20
- FDA classified
- 2023-11-08
- Posted by FDA
- 2023-11-15
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0094-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.