Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Oxycodone and Acetaminophen Tablets Recalled by Mayne Pharma Inc Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mayne Pharma Inc directly.
Affected Products
Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC 68308-841-01.
Quantity: 6456 bottles
Why Was This Recalled?
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mayne Pharma Inc
Mayne Pharma Inc has 6 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report