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Browse Drug Recalls

6,228 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,228 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 6,228 FDA drug recalls.

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DateProductReasonClassFirm
Jun 19, 2019 LIDOCAINE HCL 2% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 34... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Copper 0.4MG/ML (PVF) INJECTION SOLUTION, 10 ML per vial, RXQ Compounding, 34... 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 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 FOLIC ACID 5MG/ML INJECTION SOLUTION (MDV), 10 ML per vial, RXQ Compounding, ... 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 TURBO DROPS (PHEN 10% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per dr... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 RIBOFLAVIN 0.1% OPHTHALMIC SOLUTION SYRINGE, 2 ML per syringe. RXQ Compoundin... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 PREDNISOLONE 1%, MOXIFLOXACIN 0.5% OPHTH SOL, 5ML per dropper bottle, RXQ Com... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 BUFFERED LIDOCAINE HCL 1% INJECTION SOL (PF) SYR, 0.5 ML per vial, RXQ Compou... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 diazePAM 5 MG/ML INJECTION SOLUTION (C-IV) SYR, 2 ML per syringe, RXQ Compoun... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 HYDROXOCOBALAMIN 1000 MCG/ML (MDV), 30 ML per vial, RXQ Compounding, 340 West... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 KETAMINE 50 MG/ML (NPV) INJECTION SOLUTION (C-III), 10 ML per vial, RXQ Compo... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 TURBO CAINE 2.5 (PHEN2.5/CYCLO1/ TROP1/TETRA 0.5), 0.4 ML per Syringe, RXQ Co... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 CYANCOBALAMIN 1200MCG/ML MDV INJECTION, 30 ML per vial, RXQ Compounding, 340 ... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 TURBO DROPS (PHEN 2.5% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per d... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 RXQ CAIN (PHENYLEP 1.5%/ LIDO 1% OPHTH SOL (PF), 1 ML PER VIAL, RXQ Compoundi... 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 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 MAGNESIUM 200 MG/ML/ CALCIUM GLUC 6MG/ML/ ZINC 1MG/ML, 5ML per vial, RXQ Comp... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 STERILE WATER FOR INJECTION USP, [10, 30, or 50 ML] per Vial, RXQ Compounding... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MIC B12 W/B6 (LIPOSTAT PLUS) 25/50/50/1/.175 MG/ML, 30 ML per vial, RXQ Compo... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 METHYLCOBALAMIN 1 MG/ML (MDV) INJECTABLE SOLUTION, 10 ML per vial, RXQ Compou... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Edetate Disodium150mg/mL PFV, 10 ML per Vial, RXQ Compounding, 340 West State... 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 SOD-PHOS (PHOS 3MMOL/ML-SOD 4MEQ/ML) PFV INJ SOLN, 10 ML PER VIAL, RXQ Compo... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 BUFFERED LIDOCAINE HCL 1% INJECTION SOLUTION (PF), 10ML per vial, RXQ Compoun... Lack of Assurance of Sterility Class II RXQ Compounding LLC
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 12, 2019 HERCEPTIN 400 MG / 250 ML NS IVPB; HERCEPTIN 340 MG /250 ml 0.9% NACL IVPB; H... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 CETUXIMAB 335 MG / 167.5 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the ... 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 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 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.

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.