Browse Drug Recalls
17,897 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,897 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 17,897 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 19, 2019 | FOLIC ACID 10MG/ML INJECTION SOLUTION (MDV), 5 ML per vial, RXQ Compounding, ... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | fentaNYL 0.05MG/ML INJ SOL (PF), 55ML per syringe (C-II) RXQ Compounding, 340... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | MOXIFLOXACIN 0.5% OPHTH SOLUTION SYRINGE, 1 ML per syringe, RXQ Compounding, ... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | ZINC SULFATE 1MG/ML INJECTION SOLUTION (PFV), 10ML per VIAL, RXQ Compounding,... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | DEXTROSE 50% INJECTION SOLUTION (PF) SYRINGE, 50 ML per syringe, RXQ Compound... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | DEXPANTHENOL 250MG/ML (MDV) INJECTION SOLN, 30ML per vial, RXQ Compounding, 3... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | TURBO DROPS (PHEN 0.625%/CYCLO 0.25%/TROP 0.25%/KETO 0.125%) OPHTH SOLN, 0.4 ... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | CALCIUM CHLORIDE 100MG/ML (PFV) INJ SOLN, 10 ML per vial, RXQ Compounding, 34... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | EPHEDRINE 5MG/ML (PF) SYRINGE, 5 ML per syringe, RXQ Compounding, 340 West St... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | EPINEPHrine 4MG ADDED TO D5W 5%, 250 ML per bag, RXQ Compounding, 340 West St... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | Avastin, 25MG/ML Syringe, [a) 0.1 mL NDC 70731-0197-91; b) 0.12 mL NDC 70731-... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | HYDROGEN PEROXIDE 3% INJECTABLE PFV, 30 ML per vial, RXQ Compounding, 340 Wes... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | MOLYBDENUM 0.025MG/ML INJECTION SOLUTION, 10ML per vial, RXQ Compounding, 340... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | TAURINE 50 MG/ML (MDV) INJECTABLE, 30 ML per Vial, RXQ Compounding, 340 West ... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 18, 2019 | Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Sing... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premie... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syri... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50m... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SD... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Ba... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SD... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premie... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL St... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), ... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 18, 2019 | Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, ... | Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... | Class II | Premier Pharmacy Labs Inc |
| Jun 17, 2019 | Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g bo... | Failed Stability Specifications: Out of specification for viscosity. | Class III | Bausch & Lomb |
| Jun 14, 2019 | Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Golden State Medical Supply Inc. |
| Jun 14, 2019 | Losartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Golden State Medical Supply Inc. |
| Jun 14, 2019 | Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Golden State Medical Supply Inc. |
| Jun 14, 2019 | Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90 | CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... | Class II | Golden State Medical Supply Inc. |
| Jun 13, 2019 | Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured ... | Failed Stability Specifications | Class II | Baxter Healthcare Corporation |
| Jun 13, 2019 | Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextr... | Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa pot... | Class II | B. Braun Medical Inc |
| Jun 12, 2019 | INJECTAFER 720 MG in 100 ml NS IVPB; INJECTAFER 210 MG in 100 ml NS IVPB, Rx ... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | DIPHENHYDRAMINE 25 MG/50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Av... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | DOCETAXEL 60 MG / 250 ml D5W IVPB; DOCETAXEL 71 MG/ 250 ML NS IVPB; DOCETAXEL... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | TOPOTECAN 1.24 MG / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13th... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | FERRIC CARBOXYMALTOSE 750mg/50ml NS IVPB, Rx Only, Infusion Options, Inc. 592... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | Fluorouracil 560 MG / 11.2 ML IVP Fluorouracil 3340 MG QS 92 ML 0.9% NACL F... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G; Cisplatin 80 MG / 250 ml... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | GAZYVA 100 MG IN 250 ML NS IVPB; GAZYVA 900 MG IN 250 ML NS IVPB, Rx Only, In... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IV... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | LEUCOVORIN 560 MG / 250 ML NS IVPB; LEUCOVORIN 830 MG / 250 ml NS IVPB; LEUCO... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
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.