Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 19, 2019 | KETAMINE 10 MG/ML INJ SOL SYR (C-III), [a) 2 ML NDC: 70731-0132-02; b) 5 ML N... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | METHYLCOBALAMIN (PFV) 10 MG/ML INJECTABLE, 10 ML per vial, RXQ Compounding, 3... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | PYRIDOXINE (PFV) 100MG/ML, 30ML PER VIAL. RXQ Compounding, 340 West State Str... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | LIDOCAINE 0.75%/Epinephrine 0.025%/BSS 0.56ML SYR, 1 ML PER Syringe, RXQ Comp... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | EDETATE DISODIUM 15% INJECTABLE, 30 ML per vial, RXQ Compounding, 340 West St... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 (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 | 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 | 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 | 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 | 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 12, 2019 | MITOMYCIN 10 MG /20 ML IVP SYRINGE, Rx Only, Infusion Options, Inc. 5924 13th... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | DECITABINE 40 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the... | 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 | SOLIRIS 1200 MG QS 240 ML NACL0.9% IVPB; SOLIRIS 900 MG QS 180 ML NACL 0.9% I... | Lack of Assurance of Sterility | Class II | Infusion Options, 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 | OPDIVO 200 mg /100 ML NS VPB; OPDIVO 480 mg/100 ML NS IVPB, Rx Only, Infusion... | 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 | ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ ... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | DEXAMETHASONE 10 MG / 50 ML NS IVPB; DEXAMETHASONE 5 MG / 50 ML NS; DEXAMETHA... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | PACLITAXEL 258 MG / 500 ML NS IVPB; PACLITAXEL 318 MG / 500 ML NS IVPB; PACLI... | 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 | 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 | RAMUCIRUMAB 457 MG QS 250 ML NS IVPB; AMUCIRUMAB 1182 MG QS 250 ML NS IVPB; R... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | PERTUZUMAB 840 MG/250 ml0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 ... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Inf... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | CARBOPLATIN 174 MG / 250ml NS IVPB; CARBOPLATIN 240 MG / 250 ML NS IVPB; CARB... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | BORTEZOMIB 2.5 mg / 1 ML SQ SYRINGE; BORTEZOMIB 2.88 MG / 1.15 ML SQ SYRINGE;... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | DACARBAZINE 680 MG in 250 ml NS; DACARBAZINE 675 MG in 250 ml NS, Rx Only, In... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | Durvalumab 651 mg/ 250 ml NS IVPB; Durvalumab 650 mg/ 250 ml NS IVPB, Rx Only... | 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 | IRON SUCROSE 200 mg / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | IFOSFAMIDE 9200 MG / 1 L NS IVPB WITH MESNA 9200 MG, Rx Only, Infusion Option... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | PEMETREXED 910 MG QS 100 ML NS IVPB; PEMETREXED 940 mg QS 100 ml NS IVPB; PE... | Lack of Assurance of Sterility | Class II | Infusion Options, Inc. |
| Jun 12, 2019 | ONDANSETRON 8 MG / 50 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the ... | 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 | FOSAPREPITANT 150 mg/150 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13t... | 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. |
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.