Browse Drug Recalls
14,449 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,449 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 14,449 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Ertapenem (Invanz) 1GM NS 100ML, antibiotic, use with home pump, Rx Only, Se... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | KYTRIL 350MCG IN 3.5ML NS SYRINGE, antimetic, Rx Only, Sentara Home Infusion ... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | CEFTRIAXONE (a) 2GM in NS 100ml, (b) 4GM IN NS 200ML, Antibiotic, used with a... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | FLUCONAZOLE 200MG NS 100ML, antifungal, Rx only, Sentara Home Infusion Pharma... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | D5 NS 2300ML, Sentara Home Infusion Pharmacy Services, 535 Independence Pkwy,... | 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 | TOBRAMYCIN 660MG IN NS 66ML, antibiotic, Rx Only, use with homepump, Sentara ... | 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 | PANTOPRAZOLE 30MG IN NS 7.5ML, SYRINGE, antimetic, Rx only, Sentara Home Infu... | 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 | CEFAZOLIN 5mg/mL/HEPARIN 100unit/ml 1.5ML SYR, antibiotic, Sentara Home Infus... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | ONDANSETRON 8MG IN NS 100ML, antimetic, Rx Only, Sentara Home Infusion Pharma... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | CEFAZOLIN (a) 12GM IN NS 600ML, (b) 2GM IN NS 100ML, (c) 2GM/20ML SW SYRINGE,... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | PENICILLIN (a) 40MU IN D5W 400ML(CONTINUOUS), (b) 40U IN D5W 400ML(CONTINUOUS... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | PIPERACILLIN / TAZOBACTAM (a) 4.5GM IN NS 100 ML, (b)18GM IN NS 267M, (c) 27G... | 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 | Methylprednisolone 12MG IN NS 1.2ML SYRINGE, steroid, Rx Only, Sentara Home I... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | NALBUPHINE (a) 1.5MG IN 1.5ML NS, (b) 2.5MG IN 2.5ML NS, SYRINGE, pain, Rx On... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | HYDROCORTISONE 9a) 2MG IN NS 0.2ML SYRINGE, 9MG IN NS 2ML SYRINGE, steroid, R... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | NAFCILLIN 24GM IN NS 1200ML, antibiotic, Rx Only, use with a Curlin pump, Sen... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| 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 | GLUTATHIONE L REDUCED 100MG/ML (2ML NEBVL) INHALATION; GLUTATHIONE L REDUCED ... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | METHION/INOSIT/CHOLINE/CYANOCOBAL 25MG/50MG/50MG/1MG/ML (1ML VIAL) INJECTABLE... | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | TOBRAMYCIN FORTIFIED 15MG/ML OPH SOLUTION, 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 | 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 | Acetylcysteine 10% Ophthalmic Solution, 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 | 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 |
| 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 | 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 | 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 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 | 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 | 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 |
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.