Class II · Moderate risk
Betamethasone Dipropionate Lotion USP
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
FDA Drug Recalls
11,818 recalls · Class II, newest first
Class II · Moderate risk
PHENOBARBITAL Sodium Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PHENOBARBITAL Sodium Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
PAPAVERINE HYDROCHLORIDE Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
TETRACAINE 1% Tetracaine HCI Injection
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
Class II · Moderate risk
Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Phenylephrine HCl Injection in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Class II · Moderate risk
Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride
Defective container
Class II · Moderate risk
Sucralfate Oral Suspension
Labeling: Label Mix-Up
Class II · Moderate risk
Rock Town - Distillery - Hand Sanitizer
CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
Class II · Moderate risk
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Super Potent and Failed Reconstitution Time
Class II · Moderate risk
NAD+ Nicotinamide Adenine Dinucleotide
Product found to be Sub Potent or Exceeded reconstitution time
Class II · Moderate risk
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 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 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.