Browse Drug Recalls
6,322 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,322 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 6,322 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 27, 2022 | DAPTOMYCIN (a) 400MG IN NS 20ML, (b) 550MG IN NS 27.5ML, antibiotic, Rx only,... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara ... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | METHADONE (a) 2.5MG IN 5ML NS SYRINGE, (b) 4MG IN 5ML NS SYRINGE, pain, Rx On... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | 0.9% Sodium Chloride, used as a diluent or hydration, packaged volume of (a)... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | MYCAMINE 100MG IN NS 100ML, antifungal, Rx Only, use with a homepump, Sentara... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | TPN 107gm/AA, 200gm/DEX, 50gm/LIP 2250mL, (b) 108GM/AA, 330GM/DEX 3000ML, (c)... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | CEFEPIME, (a) 2GM IN NS 100ML (b)8GM IN NS 400ML (c) 12GM IN NS 600ML, used w... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | LEVOTHYROXINE 25MCG IN NS 1.25ML SYRINGE, Thyroid, Rx Only, Sentara Home Infu... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | MEROPENEM (a) 1000MG IN NS 250ML, (b) 2GM IN NS 100ML, (c) 500mg IN NS 125ML,... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | AMPICILLIN 8GM IN NS 400ML, antibiotic, used with Curlin pump, Sentara Home I... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | DAPTOMYCIN (a)360MG in NS 18ML syringe (b)580MG IN NS 29ML syringe(c) 630MG ... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Ethyl Alcohol 95% (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 | Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharma... | 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 | 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 | 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 | 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 | LIDOCAINE-PF- 5% (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W... | 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 | 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 | 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 | 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 | 5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, ... | 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 | PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTA... | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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.