Class II · Moderate risk
Acamprosate Calcium
Failed Dissolution Specifications
FDA drug recalls in 2026
Every FDA drug recall initiated in 2026, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
563 recalls, newest first.
Class II · Moderate risk
Dicyclomine Hydrochloride Capsules
shortfill; reports of empty capsules.
Class II · Moderate risk
Azelaic Acid Gel
CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described as grainy, gritty, or sandy) were received.
Class II · Moderate risk
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops.
Class I · High risk
Cyclophosphamide for Injection
Presence of Particulate Matter; identified as stainless steel
Class I · High risk
Cyclophosphamide for Injection
Presence of Particulate Matter; identified as stainless steel
Class III · Low risk
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag
Incorrect Product Formulation
Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Class III · Low risk
Dabigatran Etexilate Capsules
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Naropin (ropivacaine hydrochloride Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Lidocaine HCl Injection
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Glycopyrrolate Injection
Presence of Particulate Matter: Hair was found in product
Class III · Low risk
Lidolog Kit
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Class II · Moderate risk
Glycopyrrolate Oral Solution
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Rohto Cooling Eye Drops Cool Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Dry Aid
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Dry Aid
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Digi Eye
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Optic Glow
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Max Strength
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Max Strength
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops ALL-IN-ONE
Lack of Assurance of Sterility