← FDA ENFORCEMENT
D-0094-2024Class III
Zyla Life Sciences US Inc.
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
Zyla Life Sciences US Inc.
Product type
Drug
Status
Ongoing
Report date
2023-11-15
Distribution
Nationwide
Firm state
IL
Product quantity
3,792 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason for recall
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
Code / lot info
Lot 22W02, Exp 01/31/2025
Other recalls SPEQ maps to Validation & Qualification
2026-10-21Class IIZydus Pharmaceuticals (USA) Inc2026-10-21Class IIIMagellan Diagnostics, Inc.2026-10-21Class IIMicrogenics Corporation2026-10-14Class IICipla USA, Inc.
See all Validation & Qualification recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →