Class III · Low risk
Dextroamphetamine Saccharate
Failed Impurities/Degradation Specifications:
Class III drug recalls - low risk
Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
Class III · Low risk
TopCare Health 70% Isopropyl Alcohol
Cross Contamination with Other Products.
Class III · Low risk
Kroger 70% Isopropyl Alcohol
Cross Contamination with Other Products.
Class III · Low risk
Readyprep Pvp
Subpotent drug
Class III · Low risk
Sensodyne PRONAMEL
Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton
Class III · Low risk
Albuterol Sulfate
Failed Stability Specifications: Out of specification results was observed in Induction Port during the analysis of Particle size distribution at the 12-month time point.
Class III · Low risk
Fluorescein 2% Ophth
Subpotent Drug
Class III · Low risk
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Sub-Potent Drug: Subpotent assay results during stability testing.
Class III · Low risk
Pitavastatin Tablets
Failed Impurity/Degradation Specifications
Class III · Low risk
Pitavastatin Tablets
Failed Impurity/Degradation Specifications
Class III · Low risk
Testosterone 200 mg Pellet packaged in 1mL amber vials
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Class III · Low risk
Pitavastatin Tablets
Failed Impurities/Degradation Specifications.
Class III · Low risk
Pitavastatin Tablets
Failed Impurities/Degradation Specifications.
Class III · Low risk
Famciclovir Tablets
Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle.
Class III · Low risk
Levothyroxine Sodium Tablets
Presence of a foreign substance: black hair found embedded in tablet.
Class III · Low risk
Ezetimibe and Simvastatin Tablets
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
Class III · Low risk
HYDROmorphone Hydrochloride 50mg/50mL
Superpotent Drug: Assay/potency result for hydromorphone HCl in the compounded stability lot was higher than specification..
Class III · Low risk
Gabapentin Capsules
Cross Contamination
Class III · Low risk
Gabapentin Capsules
Cross Contamination
Class III · Low risk
Tolterodine Tartrate Extended-Release Capsules
Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Class III · Low risk
Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Solution
Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product specifications of 90.0-110.0% of the label claim.
Class III · Low risk
Livalo (pitavatstatin)
Presence of foreign tablets/capsules
Class III · Low risk
Badger 50
Labeling: Missing Label: The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use.
Class III · Low risk
Venlafaxine Extended-Release Tablets
Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Class III · Low risk
Guaifenesin and Codeine Phosphate Oral Solution USP
Superpotent; sodium benzoate preservative