Class II · Moderate risk
Bicillin L-A
CGMP Deviations; particulates identified during visual inspection
FDA drug recalls in 2025
Every FDA drug recall initiated in 2025, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
778 recalls, newest first.
Class II · Moderate risk
Bicillin L-A
CGMP Deviations; particulates identified during visual inspection
Class II · Moderate risk
Semaglutide
Subpotent Drug
Class II · Moderate risk
Semaglutide
Subpotent Drug
Class III · Low risk
Fluorescein 2% Ophth
Subpotent Drug
Class II · Moderate risk
Semaglutide
Subpotent Drug
Class II · Moderate risk
Cinacalcet Tablets 90 mg
Failed Dissolution Specifications.
Class III · Low risk
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk
Epinephrine Lidocaine HCL
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk
Rizatriptan Benzoate Tablets
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II · Moderate risk
Rizatriptan Benzoate Tablets
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Class II · Moderate risk
Rite Aid Pharmacy
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk
Good Neighbor Pharmacy
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk
H-E-B
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk
ReliOn
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk
CURAD Alcohol Prep Pads
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk
Medline Alcohol Prep Pads
Subpotent Drug- isopropyl alcohol levels fall below the labeled concentration.
Class II · Moderate risk
Timolol Maleate Ophthalmic Solution USP
Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
Class II · Moderate risk
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Class II · Moderate risk
Peripheral Parenteral Nutrition
Lack of Processing Controls; prescriptions were compounded in an ISO-5 area where it was identified that a daily cleaning step was not sufficiently documented.
Class II · Moderate risk
Budesonide Inhalation Suspension
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
Class II · Moderate risk
Omeprazole Delayed-release Capsules
Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class II · Moderate risk
Duloxetine Delayed-Release Capsules
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Class I · High risk
Buffered Penicillin G Potassium for Injection
Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
Class I · High risk
Cefazolin for Injection
Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin