Why it was recalled
Sub-potent Drug: Lower potency than labeled.
Product description
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
Lot numbers, UPCs & expiration codes
Lot 22W02, Exp 01/31/2025
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0094-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Oct 20, 2023
- FDA report date
- Nov 15, 2023
- Quantity
- 3,792 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zyla Life Sciences US Inc.
Original FDA data
Every field from FDA enforcement report D-0094-2024, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 93254
- Address
- 100 Saunders Rd
- Address (line 2)
- Ste 300
- Code information
- Lot 22W02, Exp 01/31/2025
- Postal code
- 60045-2502
- Report date
- Nov 15, 2023
- Product type
- Drugs
- Recall number
- D-0094-2024
- Classification
- Class III
- Recalling firm
- Zyla Life Sciences US Inc.
- Product quantity
- 3,792 bottles
- Reason for recall
- Sub-potent Drug: Lower potency than labeled.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Oct 20, 2023
- Initial firm notification
- Letter
- Center classification date
- Nov 8, 2023