Class III · Low risk
Gatifloxacin Ophthalmic Solution 0.5%
Labeling: Incorrect or missing package insert.
FDA Drug Recalls
1,525 recalls · Class III, newest first
Class III · Low risk
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension
Labeling: Incorrect or missing package insert.
Class III · Low risk
Bimatoprost Ophthalmic Solution 0.03%
Labeling: Incorrect or missing package insert.
Class III · Low risk
Isotretinoin Capsules
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Class III · Low risk
Levetiracetam Injection
Labeling: Incorrect or Missing Package Insert - the incorrect package insert version was attached.
Class III · Low risk
Methylphenidate Hydrochloride Oral Solution 5mg per 5mL
Presence of Foreign Substance; Fiber particles.
Class III · Low risk
Motion Sickness Strips
Subpotent Drug
Class III · Low risk
Wal-Dram 2
Subpotent Drug
Class III · Low risk
Motion Sickness
Subpotent Drug
Class III · Low risk
Zentrip (meclizine Hydrochloride)
Subpotent Drug
Class III · Low risk
Sankaijo BOTANICAL LAXATIVE
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
Class III · Low risk
Testosterone Cypionate Injection
Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1 ml single-dose vials, found to contain shelf cartons labelled as Testosterone Cypionate Injection USP, 200mg/mL, 10 ml multi-dose vials which contain Testosterone Cypionate Injection USP, 200mg/mL,1mL single-does vials
Class III · Low risk
Benazepril HCl Tablets
Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle
Class III · Low risk
Sodium Chloride Injection USP 0.9%
Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.
Class III · Low risk
Zarontin (ethosuximide capsules, USP)
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class III · Low risk
ethosuximide capsules
Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class III · Low risk
Gatifloxacin Ophthalmic Solution 0.5%
Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Class III · Low risk
Matzim LA (Diltiazem Hydrochloride)
GMP Deviation: lot not intended for commercial distribution.
Class III · Low risk
Lamivudine Tablets
Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.
Class III · Low risk
minolira (minocycline hydrochloride)
Failed Dissolution Specifications:
Class III · Low risk
Pramipexole Dihydrochloride Tablets 0.125 mg
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Class III · Low risk
Clotrimazole and Betamethasone Dipropionate Cream USP
Temperature Abuse: Complaints received of liquidy texture.
Class III · Low risk
Eptifibatide Injection
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class III · Low risk
Eptifibatide Injection
Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class III · Low risk
Eptifibatide Injection
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.