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Drug recalls, by class and condition

Every Class I, II, and III recall from the FDA Enforcement Report database, in chronological order. Class I is the most serious.

In the last 30 days, FDA issued 1 Class I recall (most serious), 16 Class II, and 8 Class III affecting the medications we cover.

Sourced from FDA Enforcement Reports. Verify on FDA →

Verified from FDA on Refreshes every 6 hoursFDA-Sourced

June 9, 20211 recall

June 2, 20219 recalls

RecallClassStatus
bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724CGMP Deviations: Intermittent exposure to temperature excursion during storage. · Cardinal Health Inc. · 32 bottlesClass IITerminatedDaytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.Defective Delivery System: The number of customer complaints for ripping patches and tight… · Noven Pharmaceuticals Inc · 6,689 boxesClass IIOngoingBanophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-60 Distributed by: Major Pharmaceuticals 31778 Enterprise Drive Livonia, MI 48150 USACGMP Deviations: Intermittent exposure to temperature excursion during storage. · Cardinal Health Inc. · 88 bottlesClass IITerminatedIBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS)CGMP Deviations: Intermittent exposure to temperature excursion during storage. · Cardinal Health Inc. · 345 CARTONSClass IITerminatedLamotrigine Extended-Release Tablets 250 mg 30 Tablets Rx Only NDC 49884-604-11 Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Zhejiang 317024 China For Par Pharmaceutical Companes, Inc. Spring Valley, NY 10977 U.S.A.CGMP Deviations: Intermittent exposure to temperature excursion during storage. · Cardinal Health Inc. · 131 bottlesClass IITerminatedPantoprazole Sodium Delayed-Release Tablets, USP 20 mg* 90 Tablets Rx Only NDC 62175-180-46 Distributed by: Kremers Urban Pharmaceuticals Inc. Princeton, NJ 08540, USACGMP Deviations: Intermittent exposure to temperature excursion during storage. · Cardinal Health Inc. · 4 bottlesClass IITerminatedLEVOXYL Tablets, USD, 150MCG, 100-count bottle, Rx Only, Distributed by Pfizer Inc., New York, NY 10017, MADE IN AUSTRIA, NDC: 60793-858-01CGMP Deviations: Intermittent exposure to temperature excursion during storage. · Cardinal Health Inc. · 13 bottlesClass IITerminatedLevothyroxine Sodium Tablets, USP 125 mcg (0.125 mg) 90 Tablets Rx only NDC 0378-1813-77 Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.CGMP Deviations: Intermittent exposure to temperature excursion during storage. · Cardinal Health Inc. · 112 bottlesClass IITerminatedTRAZODONE HYDROCHLORIDE TABLETS, USP 50MG 100 TABLET 10X10UD; NDC/UPC 0904-6868-61; RX; TABLETSCGMP Deviations: Intermittent exposure to temperature excursion during storage. · Cardinal Health Inc. · 91 CARTONClass IITerminated

Recalls by condition

How FDA classifies recalls

Class I: The drug may cause serious health consequences or death. Examples include the wrong drug in a bottle, a drug contaminated with bacteria, or a life-threatening allergen not declared on the label.

Class II: The drug may cause temporary or medically reversible adverse health consequences, or the probability of serious consequences is remote. Examples include a dissolution failure, a labeling error that affects dosing, or a nitrosamine impurity above the daily intake limit.

Class III: Use of the drug is unlikely to cause adverse health consequences, but the product violates FDA regulations. Examples include an incorrect tablet count per bottle, minor labeling issues, or packaging defects.

Definitions sourced from FDA Recall Classifications →

Frequently Asked Questions

What is the difference between Class I, II, and III drug recalls?
FDA classifies recalls by health risk. Class I means the drug can cause serious harm or death. Class II means temporary or reversible adverse health consequences are possible. Class III means the recall is unlikely to cause harm but the product violates FDA regulations.
How often is the FDA recall list updated?
FDA publishes the Enforcement Report weekly. MedivaScan refreshes from openFDA every 6 hours, so new recalls typically appear here within hours of FDA posting them.
What should I do if my medication appears on this list?
Contact a pharmacist or prescriber for guidance. Do not stop taking a medication based on a recall notice alone. The prescriber will advise on substitutes or whether the specific lot affects you. Each recall row links to a drug detail page with the affected lot range and the FDA product description.
Where does the recall data come from?
All data is sourced from the FDA Drug Enforcement Report endpoint via openFDA. Each row links to the canonical FDA notice for verification. MedivaScan does not add, modify, or interpret FDA's underlying record.
For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.