Lake Forest, IL, United States
Zyla Life Sciences US Inc. recalls
1 recall recorded since 2018, most recently on 20 October 2023. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class III Drugs
- Recall started
- 20 October 2023
- Reason
- Sub-potent Drug: Lower potency than labeled.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0094-2024
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.