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Browse Drug Recalls

1,301 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,301 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 1,301 FDA drug recalls in IL.

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DateProductReasonClassFirm
Jul 17, 2015 lidocaine HCl, 2%, 20 mg per mL (60 mg per 3 mL), 3 mL Total Volume, Product ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 morphine Sulfate, 2 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in ... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 rocuronium Bromide, 10 mg per mL, 50 mg per 5 mL, Preservative Free, 5 mL Tot... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 0.9% Sodium Chloride Injection USP, 50 mL Single Dose VIAFLEX Container bags,... Presence of Particulate Matter: Customer complaint for an insect found free floating inside a sin... Class I Baxter Healthcare Corp.
Jul 17, 2015 HYDROmorphone HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 ketamine HCl, 10 mg per mL, 50 mg per 5 mL, in 0.9% Sodium Chloride, 5 mL Tot... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 17, 2015 morphine Sulfate, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, Prese... Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... Class II Pharmedium Services, LLC
Jul 2, 2015 0.9% Sodium Chloride Injection USP, 500 mL in VIAFLEX Plastic Container, Baxt... Presence of Particulate Matter and Lack of Assurance of Sterility: The firm received a complaint ... Class II Baxter Healthcare Corp.
Jul 2, 2015 0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufact... Lack of assurance of sterility: Potential channel leaks near the threaded vial port. Class II Hospira Inc.
Jun 30, 2015 KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Via... Crystallization; identified as calcium salt of Ketorolac Class II Hospira Inc.
Jun 30, 2015 KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vi... Crystallization; identified as calcium salt of Ketorolac Class II Hospira Inc.
Jun 4, 2015 Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured ... Failed Impurities/Degradation Specifications; out-of-specification for color, impurity, and degra... Class II Fresenius Kabi USA, LLC
Jun 3, 2015 Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 50... Subpotent Drug; out of specification results for heparin raw material Class II Baxter Healthcare Corp
May 22, 2015 Morphine Sulfate, 2 mg per mL (60 mg per 30 mL) 30 mL total volume in a 35 mL... Sub-potent Drug; firm's analysis revealed subpotent result for morphine sulfate assay. Class I Pharmedium Services, LLC
May 21, 2015 CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 9... Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial... Class II Takeda Pharmaceuticals North America, Inc.
May 19, 2015 Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV... Failed pH Specifications: 12 month stability testing Class III Hospira Inc.
Apr 28, 2015 KABIVEN [(3.9%) Lipid Injectable Emulsion with (3.1%) Amino Acids and Electro... Labeling: Label Error on Declared Strength: Labeled 3.1% Amino Acids but contains 3.3% Amino Acids Class II Fresenius Kabi USA, LLC
Apr 23, 2015 Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL... Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles. Class I Hospira Inc.
Apr 23, 2015 Cytarabine Injection 100 mg/5 mL (20 mg/mL), 5 mL Single-Dose Vial (NDC 0069-... Presence of Particulate Matter Class I Mylan Institutional LLC
Apr 20, 2015 IC-GREEN (indocyanine green for injection, USP), 25 mg Kit (NDC 17478-701-02,... Subpotent Drug: Low out-of-specification potency result of the drug product. Class III Akorn, Inc.
Apr 13, 2015 Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose via... Crystallization Class II Hospira Inc.
Apr 13, 2015 Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose via... Crystallization Class II Hospira Inc.
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 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 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 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 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 HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose In... Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, ... Class I Pharmedium Services, LLC
Apr 7, 2015 Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) b... Failed Impurities/Degradation Specifications Class II Akorn, Inc.
Apr 7, 2015 Hydroxyzine Hydrochloride, oral solution, 10 mg per 5 mL, 16 fl oz (473 ml) b... Failed Impurities/Degradation Specifications Class II Akorn, Inc.
Apr 7, 2015 0.9% Sodium Chloride Injection, USP, 100 mL ADD-Vantage Unit, Rx only, Manufa... Lack of Sterility Assurance: The product has the potential to leak at the administrative port. Class II Hospira Inc.
Mar 26, 2015 Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihista... Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly ... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
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 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 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 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 23, 2015 Clinimix E 5/20 sulfite-free (5% amino-acid with electrolytes in 20% dextrose... Lack of Assurance of Sterility; increased complaints received for leaks Class II Baxter Healthcare Corp
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 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 0.9% Sodium Chloride Injection, USP, 50 mL, VIAFLEX Plastic Container Multi P... Lack of Assurance of Sterility; increased complaints received for leaks Class II 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 18, 2015 0.9% Sodium Chloride Injection, USP, 500 mL in VIAFLEX Plastic Container, Rx ... Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which ma... Class II Baxter Healthcare Corp.
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 18, 2015 5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Man... Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which ma... Class II Baxter Healthcare Corp.
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 17, 2015 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL,... Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Class II Akorn, Inc.
Mar 17, 2015 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL,... Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Class II Akorn, Inc.
Mar 17, 2015 SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL... Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. Class II Akorn, Inc.
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 BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/... Recalled products were made using an active ingredient that was recalled by a supplier due to pen... Class II the Compounder

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.