Oxycodone Tablets Recalled for Lower Potency Than Labeled
OXAYDO oxycodone 7.5 mg tablets distributed nationwide are being recalled because they contain lower potency than labeled. The affected lot is 22W02 with expiration 01/31/2025.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall for sub-potent product with no reported illnesses or injuries. Class III recalls are typically scored 1 or 2 per the rubric; the deficiency in active ingredient justifies a score of 2 rather than 1.
Plain-English summary
OXAYDO (oxycodone hydrochloride) 7.5 mg tablets distributed nationwide are being recalled because they contain lower potency than labeled. The tablets contain less active ingredient than indicated on the label.
The recall affects 3,792 bottles of Lot 22W02 with expiration January 31, 2025, distributed by Zyla Life Sciences US Inc. The affected NDC codes are 69344-213-11 and 69344-113-11.
Consumers with affected product may contact the FDA for additional information regarding this Class III recall.
The recalled product
- Product
- OXAYDO (OXYCODONE HYDROCHLORIDE)
- Brand
- OXAYDO
- Manufacturer
- Zyla Life Sciences US Inc.
- Category
- Drug — Opioid
- Hazard
- Affected units
- 3,792
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 22W02
- Exp 01/31/2025
UPCs (2)
- 0369344213119
- 0369344113112
Distribution
Distributed nationwide across the United States.
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