Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | HYDROMORPHONE (a) 1MG/ML IN NS, 50ML, 75 ML, 100ML, 175ML(NDC 00703-0018-01 ... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | VANCOMYCIN (a)700 MG NS 140ML, (b) 1000MG IN NS 200ML, abtibiotic, Rx only, u... | Lack of sterility assurance | Class II | Sentara Infusion Services |
| Dec 27, 2022 | TPN (a) 95GM/AA, 385/DEX, 50GM/LIP 1800ML, (b)TPN AA:100GM DEX:250GM LIP:50GM... | 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 | Levaquin 750MG IN D5W 150ML, antibiotic, Rx Only, use with home pump, 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL, Injectable, Rx Only, Pharmacy Inn... | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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.