Class II · Moderate risk
Extra Strength Headache
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
FDA drug recalls in 2021
Every FDA drug recall initiated in 2021, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,152 recalls, newest first.
Class II · Moderate risk
Medique Pain-Off
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Class II · Moderate risk
Physicians CARE Extra Strength PAIN RELIEVER
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Class I · High risk
kleantouch HAND SANITIZER
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Class III · Low risk
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000…
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CariFree sample boxes
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx36 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx26 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx21 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CTx7 Kit
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
Oxycodone Hydrochloride Oral Solution
Labeling: Missing Label
Class III · Low risk
Morphine Sulfate Oral Solution 100 mg per 5 mL
Labeling: Missing Label
Class I · High risk
Veklury (remdesivir)
Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of glass particulates.
Class II · Moderate risk
B-Complex
Lack of Processing Controls
Class II · Moderate risk
Methylcobalamin 12mg/ml injection
Lack of Processing Controls
Class II · Moderate risk
Carbamazepine Tablets
Failed Dissolution Specifications
Class III · Low risk
Telmisartan and Hydrochlorothiazide Tablets
Superpotent; Hydrochlorothiazide
Class I · High risk
Klean Touch Hand Sanitizer
Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapproved new drug and contains methanol
Class II · Moderate risk
Lidocaine Hydrochloride
Superpotent Drug: Minimally superpotent
Class I · High risk
Lidocaine Hydrochloride
Superpotent Drug
Class II · Moderate risk
5% Dextrose Injection
Lack of sterility assurance: bag has the potential to leak.
Class II · Moderate risk
Pain Aid Esf-
CGMP Deviations: failed stability results, inadequate laboratory investigations,
Class II · Moderate risk
Moxifloxacin
Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5 mg/mL
Class II · Moderate risk
Diclofenac Sodium Topical Solution
Defective container: Out of specification for container integrity leading to bottles leaking.