Class I · High risk
CVS Health brand Lubricating Gel Drops
Non-Sterility
FDA Drug Recalls
316 recalls, newest first
Class I · High risk
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops
Non-Sterility
Class I · High risk
CVS Health brand Lubricant Eye Drops
Non-Sterility
Class I · High risk
Leader brand Lubricant Eye Drops
Non-Sterility
Class I · High risk
CVS Health brand Lubricant Eye Drops
Non-Sterility
Class II · Moderate risk
KinderMed INFANTS' PAIN & FEVER Acetaminophen
Failed Impurities/Degradation Specifications
Class II · Moderate risk
KinderMed KIDS' PAIN & FEVER Acetaminophen
Failed Impurities/Degradation Specifications
Class III · Low risk
Tropicamide 1%
Labeling: Label Mix-Up: The label of a dropper bottle mistakenly states the container is a 0.5mL single-use syringe instead of a 5 mL dropper
Class I · High risk
Dr. Ergin's SugarMD
MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
Class II · Moderate risk
Naproxen Tablets
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class II · Moderate risk
Indomethacin 25mg Capsules
Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class II · Moderate risk
Trospium Chloride Extended-Release Capsules
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Class II · Moderate risk
Paroxetine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk
Paroxetine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk
Paroxetine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk
Paroxetine Hydrochloride Tablets USP
Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class I · High risk
LEADER brand Lubricant Eye Drops
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk
LEADER brand Dry Eye Relief
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk
LEADER brand Lubricant Eye Drops
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk
LEADER brand Lubricant Eye Drops
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk
LEADER brand Dry Eye Relief
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk
LEADER brand Eye Irritation Relief
Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class II · Moderate risk
Ranolazine Extended-Release Tablets 500mg
Failed Dissolution Specifications: Out of specification for dissolution.
Class I · High risk
Kuka Flex Forte caplets
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk
Reumo Flex caplets
Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.