Browse Drug Recalls
18,008 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 18,008 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 18,008 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | 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 | 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 | 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 | 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 23, 2022 | CVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn ... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care ... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care ... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Adventure Marine 150, First Aid Kit, containing Easy Care first aid After Bur... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Adventure First Aid 1.5, First Aid Kit, containing Easy Care first aid After ... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Easy Care First Aid Class A ANSI 25 Person, First Aid Kit, containing Easy Ca... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care ... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care ... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After ... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hyd... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| 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 | 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 | DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE; DEXAMETHASONE 24MG/ML INJECTABLE... | 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 | 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 | 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 | 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/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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 |
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.