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Browse Drug Recalls

1,198 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,198 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 1,198 FDA drug recalls in 2016.

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DateProductReasonClassFirm
Apr 20, 2016 Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 SCIATICA PILLS, packaged in 120-count bottles within a box, Made in the Peopl... Marketed Without An Approved NDA/ANDA: Products marked as dietary supplements have labeling that ... Class II Murray International Trading Co., Inc.
Apr 20, 2016 Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceu... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only,... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Co... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Br... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKO... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, C... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Mon... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compo... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by P... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 18, 2016 Vancomycin 1750 mg in 270 mL 0.9% NS bag,FOR IV USE ONLY, Baptist Health Medi... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Vancomycin 1000 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Med... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag, FOR IV U... Lack of Sterility Assurance. Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags, FOR IV USE ONL... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags, FOR I... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Remicade 600 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medica... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Nafcillin 3 grams in 277 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medi... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Cefazolin 6 grams in 292 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Med... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 TPN 2, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Me... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Daptomycin 650 mg in 50 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medic... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Piperacillin-Tazobactam 10.125 grams/NS 307 mL BAG, FOR IV USE ONLY, Baptist ... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Piperacillin-Tazobactam 13.5 grams/NS 322 mL bag, FOR IV USE ONLY, Baptist He... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 1/2 Normal Saline 2000 mL + Sodium Acetate 80 mEq., FOR IV USE ONLY, Baptist ... Lack of Sterility Assurance. Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Ascorbic Acid 500 mg (1 mL) Syringe, FOR IV USE ONLY, Baptist Health Medical ... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 70% Ethanol-lock Solution, 2 mL Syringe, FOR IV USE ONLY, Baptist Health Medi... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Vancomycin 1250 mg in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Me... Lack of Sterility Assurance. Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Bapti... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Milrinone 200 mcg/mL in a) D5W-300 mL, b) D5W-400 mL, c) D5W-500 mL and d) D... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Deferoxamine 2 grams/51 mL NS cassette, FOR SUBCUTANEOUS USE ONLY, Baptist He... Lack of Sterility Assurance. Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Sodium Chloride 0.9% 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist ... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Meropenem 2 grams in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medi... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Hydromorphone 2 mg/mL (500 mg in 250 mL NS) bag, FOR IV USE ONLY, Baptist Hea... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Water for Injection 1000 mL Bags, FOR IV USE ONLY, Baptist Health Medical Tow... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Piperacillin-Tazobactam 9 grams/NS 302 mL bags, FOR IV USE ONLY, Baptist Heal... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-... Defective Container: Excess lidding material accumulation between the seal and the cup resulting ... Class II VistaPharm, Inc.
Apr 18, 2016 Vancomycin 1500 mg in 270 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Med... Lack of Sterility Assurance. Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 TPN 1, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Me... Lack of Sterility Assurance. Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Vancomycin 750 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medi... Lack of Sterility Assurance. Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Vancomycin 500 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medi... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Clindamycin 900 mg in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Med... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Deferoxamine 4 grams/NS 101 mL Cassette, FOR SUBCUTANEOUS USE ONLY, Baptist H... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Invanz 1 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist He... Lack of Sterility Assurance. Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Vancomycin 1 grams in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Me... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Nafcillin 12 grams in 322 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Med... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5... Lack of Sterility Assurance. Class II Baptist Health Medical Towers Pharmacy and Infu...

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.