Class II · Moderate risk
Trimix (Alprostadil/Papaverine/Phentolamine)
Lack of Assurance of Sterility
FDA drug recalls in 2020
Every FDA drug recall initiated in 2020, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
930 recalls, newest first.
Class II · Moderate risk
Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 1 mg/mL 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Hydromorphone HCl 2 mg/mL Infusion 250 mL bags
Lack of Assurance of Sterility
Class II · Moderate risk
Command Brands GelAnti Bac Instant Hand Sanitizer
CGMP Deviation: Potential contamination with undeclared methanol.
Class II · Moderate risk
Day & Night Pack Ear Itch MD Anti-Itch Spray
cGMP Deviations.
Class II · Moderate risk
Ear Itch MD Anti-Itch Spray
cGMP Deviations.
Class II · Moderate risk
Ear Pain MD Pain Relief Drops with 4% Lidocaine
cGMP Deviations.
Class II · Moderate risk
Ear Pain MD Pain Relief Drops For Kids
cGMP Deviations.
Class II · Moderate risk
Nystatin Oral Suspension
Subpotent drug: Out of specification for assay at the 15-month test interval.
Class II · Moderate risk
Leiper's Fork Distillery
Labeling Not Elsewhere Classified: Product labeled to contain methanol.
Class III · Low risk
Extra Strength Headache Relief
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Class III · Low risk
Pain Relief Maximum Strength
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
Class II · Moderate risk
Jaloma Antiseptic Hand Sanitizer
cGMP deviations
Class III · Low risk
Red Cross Oral Pain
Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found within the Red Cross Oral Pain blister pack. The cotton pellet box states that the product contains "Natural Eugenol Oil" in which it does not.
Class II · Moderate risk
Hand Sanitizer
Discoloration and Presence of Foreign Substance
Class II · Moderate risk
Next Advanced Antibacterial Hand Sanitizer
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
Assured Instant Hand Sanitizer Vitamin E and Aloe
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
Assured Instant Hand Sanitizer Aloe & Moisturizers
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class II · Moderate risk
NuuxSan Instant ANTIBACTERIAL HAND SANITIZER
CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim for ethanol content and contained methanol. Other products were recalled because they were manufactured in the same facility as the product found to contain methanol.
Class I · High risk
Heparin Sodium 10
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Class I · High risk
Heparin Sodium 5
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.
Class I · High risk
Heparin Sodium 5
Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylparaben as preservatives, actually contained undeclared benzyl alcohol and did not contain any parabens.