Class II · Moderate risk
Vitamin D3 50
Lack of sterility assurance.
FDA drug recalls in 2018
Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Class II · Moderate risk
Multi Trace
Lack of sterility assurance.
Class II · Moderate risk
Vitamin B Complex
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Bromfenac Ophthalmic Solution
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin and Bromfenac
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin and Bromfenac Ophthalmic Solution
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin and Ketorolac Ophthalmic Solution 1%/0.5%/0.5%
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5%
Lack of sterility assurance.
Class II · Moderate risk
Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5%
Lack of sterility assurance.
Class II · Moderate risk
Acetylcysteine Ophthalmic Solution
Lack of sterility assurance.
Class II · Moderate risk
Domperidone 10 mg capsules
Lack of Processing Controls.
Class II · Moderate risk
Progesterone 100 mg SR capsules
Lack of Processing Controls.
Class II · Moderate risk
Promethazine Gel 50 mg/mL
Lack of Processing Controls.
Class II · Moderate risk
Testosterone 0.1% cream
Lack of Processing Controls.
Class II · Moderate risk
Progesterone 10% cream
Lack of Processing Controls.
Class II · Moderate risk
Omeprazole 4 mg/mL Suspension
Lack of Processing Controls.
Class II · Moderate risk
Nevirapine Extended Release Tablets
Failed Dissolution Specifications.
Class I · High risk
Lubrisine eye drops
Lack of Sterility Assurance and Incorrect/Undeclared excipient: Product was found to contain undeclared colloidal silver
Class I · High risk
Dyural-80 Injection Kit
Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex
Class I · High risk
Dyural-40 Injection Kit
Labeling: Not eslewhere classified - The kits include Sodium Chloride, USP, 0.9% which was recalled by the manufacturer due to the product insert incorrectly stating stoppers do not contain latex. The stoppers contain natural rubber latex
Class II · Moderate risk
Oxybutynin Chloride Tablets
Labeling: Wrong bar code
Class III · Low risk
Options Rx Anti-Oxidant Oil-Free Sunscreeen
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Class III · Low risk
Advanced Protection Sunscreen spf 30
Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
Class II · Moderate risk
Monsel's (Ferric Subsulfate)
Superpotent Drug: contains higher levels of Iron than labeled.
Class II · Moderate risk
Clopidogrel Tablets
Failed dissolution specification -Two additional lots being recalled due to Out-of-Specification results observed for dissolution at 18th month stability testing.