Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
FDA drug recalls in 2022
Every FDA drug recall initiated in 2022, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,390 recalls, newest first.
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class I · High risk
SyrSpend SF Suspending Base
Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Class I · High risk
Sodium Acetate Injection
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Class II · Moderate risk
Alprazolam C-IV 2 mg
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Class II · Moderate risk
Alprazolam C-IV 1 mg 60-count bottles
CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufacturer (Ultra Tab Laboratories Inc.)
Class II · Moderate risk
HAND SANITIZER Isopropyl Alcohol Antiseptic 75%
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
Class I · High risk
HAND SANITIZER Isopropyl Alcohol Antiseptic 75%
Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.
Class II · Moderate risk
Alprazolam Tablets
CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing process.
Class II · Moderate risk
HEB 50% Isopropyl Alcohol First Aid Antiseptic
Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces. The back label is correct. Product is packaged in dark bottles.
Class II · Moderate risk
Paliperidone Extended-Release Tablets
Failed Dissolution Specifications
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Class II · Moderate risk
0.9% Sodium Chloride Injection USP
Lack of sterility assurance: leaking bags
Class II · Moderate risk
hydrALAZINE HCl Tablets
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Class II · Moderate risk
Oxycodone Hydrochloride Oral Solution
Impurity failure at 0-time of the repackaged lot.
Class II · Moderate risk
Alprazolam Tablets
CGMP deviations
Class II · Moderate risk
Dexamethasone Elixir
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Class II · Moderate risk
All Over-The-Counter
CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.
Class III · Low risk
Sapropterin Dihydrochloride Powder for Oral Solution
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Class II · Moderate risk
Moxifloxacin Ophthalmic Solution USP 0.5%
Failed impurities/degradation specifications
Class II · Moderate risk
Olanzapine Tablets
cGmp Deviations
Class I · High risk
Sure Regular Antiperspirant Deodorant Aerosol
Chemical contamination: Presence of benzene
Class I · High risk
Sure Unscented Anti-perspirant Deodorant Aerosol
Chemical contamination: Presence of benzene
Class I · High risk
Brut Classic Antiperspirant & Deodorant
Chemical contamination: Presence of benzene