Class I · High risk Ongoing
CVS Health brand Lubricating Gel Drops (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%), packaged in 0.33 FL OZ (10 mL)…
Reason Non-Sterility
FDA Drug Recalls
316 recalls, newest first
Class I · High risk Ongoing
Rugby brand Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rugby…
Reason Non-Sterility
Class I · High risk Ongoing
CVS Health brand Lubricant Eye Drops (Propylene glycol 0.6%), packaged in a) 0.33 FL OZ (10mL) bottles (Single Pack) (NDC…
Reason Non-Sterility
Class I · High risk Ongoing
Leader brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack)…
Reason Non-Sterility
Class I · High risk Ongoing
CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack)…
Reason Non-Sterility
Class II · Moderate risk Ongoing
KinderMed INFANTS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 2 FL OZ (59 mL)…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Ongoing
KinderMed KIDS' PAIN & FEVER Acetaminophen, 160 mg per 5 mL bottles, Oral Suspension, Organic Cherry Flavor, 4 FL OZ (118 mL)…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Ongoing
Tropicamide 1% (10mg/mL), Cyclopentolate 1% (10mg/mL), Phenylephrine 2.5% (25mg/mL), Ketorolac 0.5% (5mg/mL), 5 mL bottles, For…
Reason 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 Ongoing
Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, helps support healthy glucose levels a) 60 count (UPC…
Reason MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide
Class II · Moderate risk Ongoing
Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa…
Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class II · Moderate risk Ongoing
Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Bardez, Goa…
Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class II · Moderate risk Ongoing
Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, Rx Only, Manufactured By: Sidmak Laboratories…
Reason Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc., Toronto…
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle…
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC#…
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class II · Moderate risk Ongoing
Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#…
Reason Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
Class I · High risk Ongoing
LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By Cardinal…
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, Sterile…
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, Sterile…
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Distributed…
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed By…
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class I · High risk Ongoing
LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL OZ (15…
Reason Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Class II · Moderate risk Ongoing
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited…
Reason Failed Dissolution Specifications: Out of specification for dissolution.
Class I · High risk Ongoing
Kuka Flex Forte caplets, packaged in 30-count bottles, Manufactured by: Kukamonga, Gonzalez Ortega No 170 Col Centro, 44100…
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.
Class I · High risk Ongoing
Reumo Flex caplets, packaged in 30-count boxes, Manufactured by: Grupo Yepenza de Mexico, SA de CV, Comerciantes 5824 Col Arcos…
Reason Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.