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
This recall is currently active, issued November 15, 2023. It was issued by Zyla Life Sciences Us Inc..
- Company
- Zyla Life Sciences Us Inc.
- Recall Initiated
- October 20, 2023
- Posted
- November 15, 2023
- Recall Number
- D-0094-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,792 bottles
- Firm Location
- Lake Forest, IL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Sub-potent Drug: Lower potency than labeled.
Distribution
Nationwide
Lot / Code Info
Lot 22W02, Exp 01/31/2025
Other recent Class III Drug recalls
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Via...
Slate Run Pharmaceuticals
· Mar 4, 2026
Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceutica...
Unichem Pharmaceuticals Usa Inc.
· Feb 18, 2026
parodontax (cetylpyridinium chloride)ACTIVE GUM HEALTH, Mouthwash, Mint. Net Wt 16.9 FL OZ (500 mL),...
Haleon Us Holdings Llc
· Feb 4, 2026
Glycopyrrolate Oral Solution, 1 mg/5 mL, 16 oz. (473 mL), Rx only, Manufactured by: MSN Pharmaceutic...
Novadoz Pharmaceuticals Llc
· Feb 4, 2026
Diclofenac Sodium Topical Gel, 1%, NET WT 100 g (3.53 oz), Manufactured by: DPT Laboratories, Ltd.,...
Cipla Usa, Inc.
· Jan 28, 2026