FDA Recall D-0094-2024
Zyla Life Sciences US Inc. · Lake Forest, IL
Class III Ongoing 937 days on record
Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.
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
Reason for recall
Sub-potent Drug: Lower potency than labeled.
Recall record
- Recall number
D-0094-2024- Classification
- Class III
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2023-10-20
- Classified by FDA Center
- 2023-11-08
- FDA published
- 2023-11-15
- Recalling firm
- Zyla Life Sciences US Inc.
- Firm location
- Lake Forest, IL
Drug identification
- Brand name(s)
- OXAYDO
- Generic name(s)
- OXYCODONE HYDROCHLORIDE
- Manufacturer(s)
- Zyla Life Sciences US LLC
- NDC(s)
69344-113, 69344-213- Route(s)
- ORAL
Operational response
Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.
For the official FDA enforcement record, see FDA's Recall Search.