PlainRecalls
FDA Drug Low Class III Ongoing

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

Reported: November 15, 2023 Initiated: October 20, 2023 #D-0094-2024

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

Reason for Recall

Sub-potent Drug: Lower potency than labeled.

Details

Units Affected
3,792 bottles
Distribution
Nationwide
Location
Lake Forest, IL

Frequently Asked Questions

What product 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. Recalled by Zyla Life Sciences US Inc.. Units affected: 3,792 bottles.
Why was this product recalled?
Sub-potent Drug: Lower potency than labeled.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 15, 2023. Severity: Low. Recall number: D-0094-2024.