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Browse Drug Recalls

1,392 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,392 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 1,392 FDA drug recalls in 2022.

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DateProductReasonClassFirm
Dec 22, 2022 MAGNESIUM CHLORIDE HEXAHYDRATE-PF- 200MG/ML (5ML VIAL) INJECTABLE, Rx Only, P... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 GLYCERIN/LIDOCAINE HCL/EPINEPHRINE 31%(V/V)/0.17%/0.00017% (10ML VIALS); GLYC... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 HEPARIN/LIDO HCL/SODIUM BICARB 100U/2MG/16.8MG/ML (20ML SYRINGE) IRRIGATION, ... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 METHOTREXATE INTRAVITREAL (1ML VIAL) 4MG/ML (400MCG/0.1ML) INJECTABLE, Rx Onl... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 MITOMYCIN 0.2MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.2MG/ML (1ML VIA... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Glycopyrrolate Tablets, USP, 1 mg, 50 Tablets (5x10) Unit Dose carton, Rx Onl... Failed impurities/degradation specifications: Out of specification for unknown impurities. Class II AVKARE LLC
Dec 22, 2022 GLYCERIN 72% (W/V) (15ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 293... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 EDETATE DISODIUM (VET) 1% (3ML droptainer) OPH Solution, Rx Only, Pharmacy In... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Hydroxocobalamin 25MG/ML (2ML vial) Injectable, Rx Only, Pharmacy Innovations... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 VITAMIN D3-AQUEOUS- 10,000IU/ML (1ML VIAL) INJECTABLE; VITAMIN D3-PF-ETHYL OL... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 MITOMYCIN 0.4MG/ML (1ML DROPTAINER) OPH SOLUTION; MITOMYCIN 0.4MG/ML (1ML VIA... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Epi-Caine, Epinephrine 0.025% Lidocaine HCL 0.75% Solution for Intraocular In... CGMP Deviations: Raw material recalled by repackager, due to discoloration. Class II Pine Pharmaceuticals, LLC
Dec 22, 2022 FLURBIPROFEN -CORN OIL- 0.04% (3ML DROPTAINER) OPH SOLUTION, Rx Only, Pharmac... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Sing... Presence of Particulate Matter: Glass particulate matter detected in injectable. Class I Pfizer Inc.
Dec 22, 2022 Dutasteride 0.1% (1.5ML VIAL) Injectable, Rx Only, Pharmacy Innovations, 2936... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Methylcobalamin 1MG/ML (1ML vial); Methylcobalamin 3MG/ML (1ML vial); Methylc... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 LEVEMIR-STS- 100U/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 29... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML (1ML vial) In... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Albuterol (PF/SULFURIC ACID/DYE FREE) - 3ML tube - 0.083% Inhalation Solution... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 POLIDOCANOL 50MG/ML (5%) (30ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovation... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 PROSTAGLANDIN (PE1) 45MCG (1ML VIAL) INJECTABLE PROSTAGLANDIN E1 17MCG/ML (1M... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 HYDROXOCOBALAMIN-PF- 1MG/ML (1ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovati... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innova... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 METHYLCOBALAMIN 12.5MG/ML (1ML VIAL) INJECTABLE METHYLCOBALAMIN 25MG/ML (1.2M... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Cyclosporine (A) 0.1%; Cyclosporine (A) 0.2%; Cyclosporine (A) 1%; Cyclospori... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 SEMAGLUTIDE 0.5MG/ML (0.5ML VIAL) INJECTABLE SEMAGLUTIDE 1MG/ML (0.5ML VIAL) ... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 NADH 10MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Clindamycin/EDTA Calcium 4.1667MG/0.333MG/ML (30ML syringe) Irrigation, Rx On... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Buprenorphine HCL 0.9 MG/ML (25ML vial) Injectable, Rx Only, Pharmacy Innovat... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Minoxidil 0.75% (1.5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 ... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 KETAMINE 50MG/ML (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 ... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Edetate Calcium Disodium 400MG/ML (30ML vial) Injectable, Rx Only, Pharmacy I... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Cholecalciferol (Vitamin D3) 100,000U/ML Injectable, Rx Only, Pharmacy Innova... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Ceftazidime Intravitreal (1ML vial) 22.5 MG/ML(2.25MG/0.1ML) Injectable, Rx O... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 TESTOSTERONE 3% (4GM TUBE) OPHTH OINTME TESTOSTERONE CYP/ANASTROZOLE-GS OIL- ... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Apomorphine HCL 2MG/ML (10ML vial) Injectable, Rx Only, Pharmacy Innovations,... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 ESTRADIOL CYP/TEST CYP- SS OIL- 2MG/50MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIO... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 VORICONAZOLE 10MG/ML (10ML DROPPER) OPH SOLUTION, Rx Only, Pharmacy Innovatio... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 Estradiol 0.05% OPH Solution, Rx Only, Pharmacy Innovations, 2936 W 17th St.,... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, ... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 BSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable, Rx Only, Pharmacy Innova... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 SCOPOLAMINE HYDROBROMIDE 0.25% OPH SOLUTION, Rx Only, Pharmacy Innovations, 2... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 PAPAVERINE/PHENTOLAMINE 30MG/0.5MG/ML (1ML VIAL) INJECTABLE; PAPAVERINE/PHENT... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL 25MG/25MG/25MG/25MG/... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 GENTAMICIN BLADDER 0.08MG/ML (60ML SYRINGE) IRRIGATION; GENTAMICIN BLADDER 0.... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 PHENOL 10% (10ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W 17th... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 TACROLIMUS 0.03% OPH SOLUTION TACROLIMUS 0.1% (1ML DROPTAINER) OPH SOLUTION... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 VANCOMYCIN FORTIFIED 10MG/ML (1ML DROPTAINER) OPH SOLUTION VANCOMYCIN FORTIFI... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations
Dec 22, 2022 PE1/PAPAV/PHEN 20MCG/30MG/2MG/ML (1ML VIAL) INJECTABLE PE1/PAPAV/PHEN 30MCG/3... Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. Class II Pharmacy Innovations

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.