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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
Apr 21, 2014 0.9% Sodium Chloride Irrigation, USP, 1000 mL,Not for Injection, Manufacture... Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irriga... Class II Baxter Healthcare Corp.
Apr 21, 2014 Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (2... Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible ... Class I Hospira Inc.
Apr 18, 2014 1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-do... Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, ... Class I Hospira Inc.
Apr 14, 2014 HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi... Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperid... Class III Fresenius Kabi USA LLC
Apr 2, 2014 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administr... Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during ... Class I Hospira Inc.
Mar 27, 2014 Potassium Chloride for Inj. Concentrate, USP, 40 mEq (2 mEq/mL), 20 mL Singl... Presence of Particulate; red and black particulate within the solution and embedded within the pl... Class II Hospira Inc.
Mar 25, 2014 Demerol, meperidine HCL Inj. USP, 25 mg/0.5 mL (50 mg/mL), 0.5 mL ampoules, R... Labeling; Missing label; ampoules are missing the immediate container label Class III Hospira Inc.
Mar 10, 2014 Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administra... Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defect... Class II AbbVie Inc
Mar 10, 2014 LUPRON DEPOT-PED (Leuprolide Acetate for Depot Suspension) Single Dose Admini... Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defect... Class II AbbVie Inc
Mar 10, 2014 Lupron Depot (leuprolide acetate for depot suspension) Single Dose Administra... Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defect... Class II AbbVie Inc
Mar 10, 2014 Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administra... Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defe... Class II AbbVie Inc
Mar 10, 2014 Lupron Depot (Leuprolide Acetate for Depot Suspension) Single Dose Administra... Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defect... Class II AbbVie Inc
Mar 4, 2014 Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag... Lack of Assurance of Sterility; leaking of premix bags Class II Sagent Pharmaceuticals Inc
Feb 11, 2014 Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Fl... Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag ... Class I Baxter Healthcare Corp.
Feb 11, 2014 0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hosp... Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, ... Class II Hospira Inc.
Feb 10, 2014 Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx... Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than No... Class III Pinnacle Biologics Inc
Feb 10, 2014 Bupivacaine HCl Inj. USP, 0.5% (5 mg/mL), 30 mL Single-dose Preservative Free... Presence of Particulate Matter: Confirmed customer report of visible particulate embedded in the ... Class II Hospira Inc.
Jan 28, 2014 Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets ... Failed Impurity/degradation Specification Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jan 10, 2014 DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, ... Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the... Class I Hospira Inc.
Jan 9, 2014 Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in... Lack of Assurance of Sterility; potential leakage from administrative port. Class II Hospira Inc.
Jan 9, 2014 Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Mainten... Lack of Assurance of Sterility; potential leakage from administrative port. Class II Hospira Inc.
Dec 23, 2013 Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose... Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass co... Class I Hospira Inc.
Dec 20, 2013 CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 9% Povido... Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nai... Class II Carefusion 2200 Inc
Dec 20, 2013 CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nail Cleaner With 15% Povid... Subpotent Drug: CareFusion is recalling the CareFusion Scrub Care Surgical Scrub Brush-Sponge/Nai... Class II Carefusion 2200 Inc
Dec 12, 2013 Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patie... Presence of Particulate Matter: Glass defect located on the interior neck of the vial identified ... Class II Hospira Inc.
Dec 6, 2013 FOLIC ACID INJECTION, USP; 5 mg/mL ; For IM, IV or SC Use; 10 mL; Multiple Do... Failed Impurities/Degradation specifications: out-of-specification results 14 & 15 month time point Class III Fresenius Kabi USA, LLC
Nov 21, 2013 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX... Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due t... Class I Baxter Healthcare Corp.
Nov 21, 2013 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx... Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to... Class I Baxter Healthcare Corp.
Nov 18, 2013 Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1... Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. Class I Baxter Healthcare Corp.
Nov 18, 2013 Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% De... Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. Class I Baxter Healthcare Corp.
Nov 18, 2013 Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL... Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. Class I Baxter Healthcare Corp.
Nov 18, 2013 50 mg Nitroglycerin in 5% Dextrose Injection (200 mcg/mL), 250 mL glass conta... Presence of Particulate Matter; particulate matter in one vial identified as silicone rubber and ... Class I Baxter Healthcare Corp.
Nov 12, 2013 10%, Travasol (Amino Acid) Injection, 2000 ml, Pharmacy Bulk Package Not for ... Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be... Class II Baxter Healthcare Corp.
Nov 8, 2013 PACLITAXEL INJECTION, USP (semisynthetic); 300 mg/50 mL; (6 mg/mL); Multiple ... Labeling: Incorrect or Missing Package Insert- Missing text on the product insert in the "Clinica... Class III Fresenius Kabi USA, LLC
Oct 31, 2013 Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fres... Presence of Particulate Matter: Particulate matter consistent with delamination of the glass vial... Class II Fresenius Kabi USA, LLC
Oct 18, 2013 Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-pre... Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in th... Class I Hospira Inc.
Oct 11, 2013 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patie... Presence of Particulate Matter: Visible particles embedded in the glass identified during a retai... Class II Hospira Inc.
Oct 11, 2013 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fli... Lack of assurance of sterility; equipment failure led to potential breach in asceptic process. Class II Hospira Inc.
Sep 26, 2013 LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 bl... CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 26, 2013 CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card.... CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 24, 2013 Metoclopramide Injection, USP 10 mg (5mg/mL), 2 mL Single-dose Vial, Rx Only,... Presence of Particulate Matter: Potential vendor glass issue - glass spiticules (glass strands) w... Class II Hospira Inc.
Sep 24, 2013 Ondansetron Injection, USP, 4 mg/2 mL (2 mg/mL), 2 mL Single-dose Vial, Rx On... Presence of Particular Matter: Potential vendor glass issue - glass spiticules (glass strands) we... Class II Hospira Inc.
Sep 17, 2013 Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) ... CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 17, 2013 Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) ... CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 17, 2013 Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) u... CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufa... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Sep 16, 2013 Morphine Sulfate Injection, USP, (25mg/mL), 250 mg, 10mL Fill, Single dosage ... Lack of Assurance of Sterility: Confirmed customer report of leakage of vial contents due to the ... Class II Hospira, Inc.
Sep 16, 2013 1% Lidocaine HCl Injection, USP, 10 mg/mL, NDC 0409-4276-01, Hospira, Inc., L... Presence of Particulate Matter: Oxidized stainless steel found in vial of 1% Lidocaine Hydrochlor... Class I Hospira, Inc.
Sep 9, 2013 Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 5mL, (NDC 16571-140-5... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Timolol Maleate Sterile Ophthalmic Solution, USP 0.25%, 10mL, (NDC 16571-140-... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 9, 2013 Ofloxacin Ophthalmic Solution, USP 0.3%, 5mL, (NDC 16571-130-50). The prod... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC

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.