Class II · Moderate risk
ePHEDrine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
FDA drug recalls in 2015
Every FDA drug recall initiated in 2015, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,733 recalls, newest first.
Class II · Moderate risk
ePHEDrine Sulfate
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
Buffered Lidocaine
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
Buffered Lidocaine
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
atropine Sulfate Injection
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk
atropine Sulfate Injection
Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Imipramine HCl Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Felodipine Extended-Release Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Felodipine Extended-Release Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk
Felodipine Extended-Release Tablets
Chemical Contamination; benzophenone leached from the product label varnish
Class II · Moderate risk
Phenobarbital/Hyoscyamine/ Atropine/Scopolamine…
Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Class II · Moderate risk
Sensodyne With Fluoride Repair & Protect
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
Sensodyne Extra Fresh Repair & Protect
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
Sensodyne Complete Protection
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
Sensodyne Extra Fresh Complete Protection
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
biotene PBF Toothpaste
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class II · Moderate risk
biotene Gentle Mint Gel
Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a toothbrush.
Class III · Low risk
Phentermine Hydrochloride Capsules
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Class III · Low risk
Mometasone Furoate Ointment USP
Subpotent drug
Class III · Low risk
Intermezzo
Failed dissolution specifications
Class I · High risk
Akttive High Performance Fat Burner Gold dietary supplement capsules
Marketed Without An Approved NDA/ANDA: Dietary supplements contains undeclared sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling.