Mayne Pharma Recalls Oxycodone and Acetaminophen Tablets Due to Labeling Error
Mayne Pharma is recalling 6,456 bottles of Oxycodone and Acetaminophen Tablets due to a lot number labeling error on the primary container.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding the lot number, not a product safety defect.
Plain-English summary
Mayne Pharma Inc is voluntarily recalling 6,456 bottles of Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg, 100-count. The recall is due to a labeling error where the primary container displays the incorrect lot number FG01517, while the shipper labels and invoices correctly list the lot number as FG10517. The affected products have an expiration date of 12/31/2019.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. The error is limited to the lot number printed on the bottle and does not indicate a problem with the medication itself.
Consumers and healthcare providers with these specific bottles should stop using them and contact their pharmacist or Mayne Pharma for instructions on how to return the product. The affected lot is FG10517, which is mislabeled as FG01517 on the bottle.
The recalled product
- Product
- 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.
- Manufacturer
- Mayne Pharma Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 6,456
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: FG01517
- Exp. 12/31/2019
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Mayne Pharma Inc
See all →- ModerateFDA Recalls Clonidine Transdermal Patches for Delivery System Defect
FDA (Drugs) · 2022-06-29
- ModerateLexette Topical Foam Recall Due to Dispensing Defects
FDA (Drugs) · 2022-01-26
- ModerateMayne Pharma Recalls Carbidopa and Levodopa Tablets Due to Foreign Tablet Mix-Up
FDA (Drugs) · 2020-03-18
- ModerateMayne Pharma Recalls Fabior Foam Due to Stability Test Failures
FDA (Drugs) · 2018-04-11
- ModerateMayne Pharma Recalls Liothyronine Sodium Tablets for Dissolution Failures
FDA (Drugs) · 2017-12-06
Same hazard · mis labeling
See all →- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateOxycodone and acetaminophen 10 mg tablets recalled over a missing imprint
FDA (Drugs) · 2026-01-14
- ModerateOxycodone and acetaminophen 7.5 mg tablets recalled over a missing imprint
FDA (Drugs) · 2026-01-14
- ModerateAurobindo Recalls Oxycodone and Acetaminophen Tablets Due to Water Leakage
FDA (Drugs) · 2020-04-22
- ModerateAlvogen Recalls Oxycodone and Acetaminophen Tablets Due to Uniformity Failure
FDA (Drugs) · 2014-10-01
- SevereWatson Recalls Oxycodone and Acetaminophen Tablets Due to Foreign Contamination
FDA (Drugs) · 2013-10-09
- ModerateMayne Pharma Recalls Carbidopa and Levodopa Tablets Due to Foreign Tablet Mix-Up
FDA (Drugs) · 2020-03-18