Mayne Pharma Oxycodone and Acetaminophen Tablets Recall

Why it was 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.

Product description

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.

Lot numbers, UPCs & expiration codes

Lot: FG01517, Exp. 12/31/2019

Where it was sold

Nationwide in the USA.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-1129-2018
Classification: Class III
Status: Terminated
Recall initiated: Aug 21, 2018
FDA report date: Sep 5, 2018
Quantity: 6456 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Mayne Pharma Inc

Original FDA data

Every field from FDA enforcement report D-1129-2018, exactly as published.

Show all FDA fields

City: Greenville
State: NC
Status: Terminated
Country: United States
Event ID: 80833
Address: 1240 Sugg Pkwy
Code information: Lot: FG01517, Exp. 12/31/2019
Postal code: 27834-9006
Report date: Sep 5, 2018
Product type: Drugs
Recall number: D-1129-2018
Classification: Class III
Recalling firm: Mayne Pharma Inc
Product quantity: 6456 bottles
Termination date: May 19, 2020
Reason for recall: 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.
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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.
Distribution pattern: Nationwide in the USA.
Recall initiation date: Aug 21, 2018
Initial firm notification: Letter
Center classification date: Aug 28, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1129-2018, published Sep 5, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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