American Health Packaging Recalls Mis-Labeled Ibuprofen Tablets
American Health Packaging is recalling 137,300 Ibuprofen 600 mg tablets because some cartons were mis-labeled as Oxcarbazepine 300 mg.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA classified this recall as Class I, which is the highest level of recall for serious health hazards.
Plain-English summary
American Health Packaging is recalling 137,300 tablets of Ibuprofen Tablets, USP, 600 mg (NDC 68084-0703-01). The recall involves Lot #142588, which expires in January 2016. The product was distributed nationwide and in Puerto Rico.
The recall was initiated because some cartons containing Ibuprofen 600 mg tablets were found to be mis-labeled with blister card print identifying the product as AHP Oxcarbazepine Tablets, 300 mg (Lot #142544). This labeling error could lead to patients receiving the wrong medication.
Consumers and healthcare providers should check their inventory for Ibuprofen Tablets, USP, 600 mg, Lot #142588. If found, the product should be returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions about their medication.
The recalled product
- Product
- Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, OH 43217, NDC 68084-0703-01
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Affected units
- 137,300
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 #142588
- Exp 01/2016
Distribution
Part of a larger recall action
This product is one of 2 recalled by American Health Packaging under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · American Health Packaging
See all →- LowBuprenorphine Sublingual Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-09-09
- ModerateNitrofurantoin Capsules 100 mg recalled for failed dissolution specifications
FDA (Drugs) · 2022-05-25
- ModerateCyanocobalamin Injection Recalled Due to Subpotency and Assay Non-Compliance
FDA (Drugs) · 2022-05-04
- SevereOxycodone Hydrochloride Oral Solution Recall Due to Impurity Failure
FDA (Drugs) · 2022-03-16
- ModerateMetoprolol Succinate ER Tablets Recall for Failed Dissolution
FDA (Drugs) · 2022-02-02
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 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
- SevereFDA Recalls Mislabelled Ibuprofen Tablets Distributed by Aidapak Services
FDA (Drugs) · 2014-01-22
- LowBuprenorphine Sublingual Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-09-09
- LowNabumetone Tablets Recalled for Missing Medication Guide Labeling
FDA (Drugs) · 2020-07-01
- LowDesmopressin Acetate Tablets Recalled for Incorrect Imprint
FDA (Drugs) · 2015-07-22
- LowAmerican Health Packaging Recalls bupropion Hydrochloride Extended Release Tablets
FDA (Drugs) · 2013-08-21
- LowAurobindo Recalls Children's Ibuprofen Suspension Due to Missing Dosing Cups
FDA (Drugs) · 2020-11-11