Endo Pharmaceuticals Recalls Endocet Tablets Due to Foreign Tablet Contamination
Endo Pharmaceuticals is recalling specific bottles of Endocet 10 mg/650 mg tablets because some contained mixed 10 mg/325 mg tablets.
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: The recall is classified as FDA Class III, which is defined as unlikely to cause adverse health consequences. The hazard involves a mix-up of two different strengths of the same medication, which is a labeling/quality control issue rather than a high-risk pathogen or structural defect.
Plain-English summary
Endo Pharmaceuticals, Inc. is recalling 11,764 bottles of Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count. The recall is due to a customer complaint that some bottles contained Endocet 10 mg/325 mg tablets mixed with the 10 mg/650 mg tablets.
The affected product is identified by Lot # 402794NV with an expiration date of 12/13. The NDC number is 60951-797-70. The product was distributed nationwide and in Puerto Rico.
Consumers should check their medication for this specific lot number and expiration date. If the product matches the description, they should contact their pharmacist or healthcare provider for instructions on how to dispose of the medication or obtain a replacement.
The recalled product
- Product
- Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE 68501; NDC 60951-797-70.
- Manufacturer
- Endo Pharmaceuticals, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 11,764
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 #: 402794NV
- Exp 12/13
Distribution
Related recalls
Same manufacturer · Endo Pharmaceuticals, Inc.
See all →- SevereClonazepam Tablets Recalled Due to Carton Labeling Error
FDA (Drugs) · 2024-08-07
- HighCalcitonin Salmon Nasal Spray Recalled for Out-of-Specification Impurities and Low Potency
FDA (Drugs) · 2023-04-05
- SevereEndo Pharmaceuticals Recalls Robaxin-750 Due to Incorrect Dosage Labeling
FDA (Drugs) · 2018-10-10
- SevereEndo Recalls EDEX Alprostadil Injection Due to Sterility Assurance Defect
FDA (Drugs) · 2017-03-15
Same hazard · foreign object
See all →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- ModerateBionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2026-09-09
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
Similar recalls
- SevereWatson Recalls Oxycodone and Acetaminophen Tablets Due to Foreign Contamination
FDA (Drugs) · 2013-10-09
- LowPercocet 10/325 mg Tablets Recalled Due to Foreign Tablet Presence
FDA (Drugs) · 2013-05-08
- ModerateAlvogen Recalls Oxycodone and Acetaminophen Tablets Due to Uniformity Failure
FDA (Drugs) · 2014-10-01
- HighOxycodone Hydrochloride Tablets Recalled for Foreign Tablet Contamination
FDA (Drugs) · 2021-09-22
- HighZydus Recalls Atenolol Tablets Due to Foreign Paroxetine Tablet Presence
FDA (Drugs) · 2017-03-29
- ModerateAscend Amlodipine Besylate Tablets Recalled for Foreign Tablet Presence
FDA (Drugs) · 2017-09-20