Class II · Moderate risk
Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride
Defective container
FDA Drug Recalls
1,018 recalls, newest first
Class II · Moderate risk
Sucralfate Oral Suspension
Labeling: Label Mix-Up
Class III · Low risk
Risedronate Sodium Tablets
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Class II · Moderate risk
Rock Town - Distillery - Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Class I · High risk
Meclizine Hydrochloride Tablets USP
Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled as PredniSONE Tablets. The tablets in the bottles are Meclizine Hydrochloride
Class II · Moderate risk
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Super Potent and Failed Reconstitution Time
Class III · Low risk
Hydroxocobalamin B12 1mg/mL
Sub Potent
Class III · Low risk
Sb-4
Sub Potent
Class III · Low risk
T-105
Super Potent
Class III · Low risk
Formula F9
Sub Potent
Class II · Moderate risk
NAD+ Nicotinamide Adenine Dinucleotide
Product found to be Sub Potent or Exceeded reconstitution time
Class II · Moderate risk
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
Class III · Low risk
Nandrolone Decanoate
Subpotent Drug
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