Browse Drug Recalls

1,732 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,732 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 1,732 FDA drug recalls, Class I.

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DateProductReasonClassFirm
Apr 13, 2015 EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 m... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 13, 2015 EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 ... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 13, 2015 oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 ... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 13, 2015 EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mc... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 13, 2015 HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Inj... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 12, 2015 Testosterone Cypionate 200 mg/mL in Sesame oil, 10 mL amber glass vial, Rx On... Incorrect Product Formulation: Vials labeled as Testosterone Cypionate 200 mg/mL in Sesame Oil ar... Class I Stroheckers Inc Pharmacy
Mar 24, 2015 0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactu... Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Class I Baxter Healthcare Corp.
Mar 24, 2015 5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxte... Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Class I Baxter Healthcare Corp.
Mar 24, 2015 Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by ... Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Class I Baxter Healthcare Corp.
Mar 24, 2015 10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Bax... Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal) Class I Baxter Healthcare Corp.
Mar 23, 2015 Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 23, 2015 Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 23, 2015 Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 18, 2015 CARBOplatin Injection 450 mg/45 mL (10 mg/mL), 45 mL packaged in a 100 mL Mul... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 18, 2015 Methotrexate Injection, USP 50 mg/2 mL (25 mg/mL), 2 mL Single-dose Vial, pac... Presence of Particulate Matter Class I Mylan Institutional LLC
Mar 11, 2015 LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, M... Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the soluti... Class I Hospira Inc.
Mar 10, 2015 ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semil... Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains u... Class I Ultra ZX Supplements
Mar 6, 2015 MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx onl... Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect ... Class I Hospira Inc.
Mar 5, 2015 0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospi... Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution. Class I Hospira Inc.
Jan 28, 2015 PHENYLephrine HCl, 60 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 50 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 20 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 Fentanyl Citrate, 5 mcg per mL (1,250 mcg per 250 mL), 250 mL total volume in... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 10 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 PHENYLephrine HCl, 40 mg added to 250 mL 0.9% Sodium Chloride Injection USP (... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 Bupivacaine HCl 0.0625%, 250 mL total volume in a 250 mL LifeCare Bag in Sodi... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 28, 2015 Morphine Sulfate, 1 mg per mL (250 mg per 250 mL), 250 mL total volume in a 2... Presence of Particulate Matter: The firm manufactured products using Hospira 0.9% Sodium Chloride... Class I Pharmedium Services, LLC
Jan 25, 2015 AMPD GOLD Bee Pollen capsules, 350 mg, 60-count bottle, Signature, 1027 Highw... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, making... Class I Detox Transforms
Jan 25, 2015 iNSANE Bee Pollen capsules, 200 mg, 60-count bottle, Developed by Signature, ... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein an... Class I Detox Transforms
Jan 25, 2015 EDGE Amplified Weight Release capsules, 400 mg, 60-count bottle, Developed by... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein an... Class I Detox Transforms
Jan 25, 2015 BtRiM Max capsules, 60-count bottle, Developed by Signature, 1027 Highway 70 ... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, m... Class I Detox Transforms
Jan 25, 2015 iNDiGO capsules, 220 mg, 60-count bottle, Developed by Signature, 1027 Highw... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared phenolphthalein, m... Class I Detox Transforms
Jan 20, 2015 0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Fore... Presence of Particulate Matter; Hospira has identified the particulate as a human hair, sealed in... Class I Hospira Inc.
Jan 20, 2015 Avastin (Bevacizumab) 2 mg/0.08 mL syringe, Office Administration Only, AmEx ... Non-Sterility: Product tested positive for bacterial contamination. Class I Pacifico National, Inc. dba AmEx Pharmacy
Jan 20, 2015 Avastin (Bevacizumab) 1.25 mg/0.05 mL syringe, Office Administration Only, Am... Non-Sterility: Product tested positive for bacterial contamination. Class I Pacifico National, Inc. dba AmEx Pharmacy
Jan 13, 2015 fentaNYL Citrate, Preservative Free, 10 mcg per 1 mL In 0.9% Sodium Chloride,... Subpotent Drug Class I Pharmedium Services, LLC
Jan 13, 2015 fentaNYL Citrate, Preservative Free, 5 mcg per mL In 0.9% Sodium Chloride, 1 ... Subpotent Drug Class I Pharmedium Services, LLC
Jan 6, 2015 Practi-0.9% Sodium Chloride, 50 mL, 100 mL, 250 mL, 500 mL, and 1000 mL bags,... Non-sterility: Product is made in a non-sterile facility and is not intended for use in humans or... Class I Wallcur Incorporated
Dec 19, 2014 SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc. Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutra... Class I Bethel Nutritional Consulting, Inc
Dec 17, 2014 Virginia Hospital Center (VA) TPN Neonatal Day 1 Bag, Trophamine 5.5 gm, Dext... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Abington Memorial Hospital (PA) TPN Neonatal Starter 0.4-0.599 Kg, Amino Acid... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Rose Medical Center (CO) Neonate D5 Bridge, Trophamine 3% Dextrose 5%, Additi... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag with Calcium, Tr... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Bayshore Medical Center (TX) 10% Dextrose Starter Neo TPN, Trophamine 2.4% , ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Adventist Hinsdale Hospital (IL) Neonatal Starter: Troph 4%Dex5% ,Trophamine ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Methodist Hospital Northlake (IN) Neo Starter TPN D5, AA2, Trophamine 2% Dext... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Virtua West Jersey Voorhees (NJ) TPN Neonatal Starter Bag, Trophamine 3% Dext... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Truman Medical Center Lakewood (MO) Starter TPN, Trophamine 5.25g, Dextrose 1... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Sinai Hospital (MD) TPN Neonatal Day 1 Bag, Trophamine 10 g, Dextrose 25 g, A... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, Inc.
Dec 17, 2014 Spotsylvania Regional Med Ctr (VA) TPN Neonatal Starter Bag, Trophamine 5 gm ... Non-Sterility: Out of specification results for the sterility test for microbial contamination. Class I Central Admixture Pharmacy Services, 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.