Mayne Pharma Inc recalls Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma,
Mayne Pharma recalls 100-count oxycodone and acetaminophen tablets due to mislabeled lot numbers on packaging, which could lead to confusion in tracking expiration dates.
Lower-risk 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.
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What happened, in plain English
Mayne Pharma is recalling 100-count oxycodone and acetaminophen tablets that have incorrect lot numbers on the packaging. This could cause confusion about which batch was sold and might lead to using expired medication. Read more at govinfonow.com/recall/39695-mayne-pharma-oxycodone-acetaminophen-tablets-recall-incorrect-lot-number-labeling.
Source Summary by GovInfoNow · govinfonow.com/recall/39695-mayne-pharma-oxycodone-acetaminophen-tablets-recall-incorrect-lot-number-labeling · Updated October 6, 2026 · FDA enforcement record: FDA #D-1129-2018
Cite this page
“Mayne Pharma Oxycodone/Acetaminophen Tablets Recall: Incorrect Lot Number Labeling.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39695-mayne-pharma-oxycodone-acetaminophen-tablets-recall-incorrect-lot-number-labeling. Based on FDA recall #D-1129-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1129-2018%22&limit=1).
Why it’s dangerous
The product is mislabeled with the wrong lot number (FG01517 instead of FG10517) on the primary container, shipper labels, and invoices. This could lead to confusion about which batch was sold and might result in using expired medication.
Who’s affected
Prescription holders of the 100-count bottle with lot number FG01517 are affected. Patients who have the product may be at risk if they use it after the expiration date due to mislabeling.
How to tell if you have this one
Check for the lot number FG01517 on the primary container, shipper labels, and invoices. The product was sold with the expiration date 12/31/2019.
- Brand
Mayne Pharma- Category
Drug
What to do — step by step
Check Product Labeling
Verify the lot number on the primary container, shipper labels, and invoices to ensure it matches FG01517.
Questions people ask
Why is this product being recalled?
The product has incorrect lot numbers on the packaging, which could lead to confusion about which batch was sold and might result in using expired medication.
What should I do if I have this product?
Check the lot number on the primary container, shipper labels, and invoices to ensure it matches FG01517. If it does not match, contact Mayne Pharma for further instructions.
Is there a risk of serious injury from this product?
The recall is for mislabeling, which could lead to using expired medication, but there is no indication of immediate safety risks.
Contact Mayne Pharma
We’ve drafted a message you can send Mayne Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-1129-2018 — Mayne Pharma Mayne Pharma Hello, I own a Mayne Pharma that is covered by recall D-1129-2018 from Mayne Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1129-2018 (August 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1129-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.