Browse Drug Recalls

1,317 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,317 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 1,317 FDA drug recalls in IL.

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DateProductReasonClassFirm
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
Sep 9, 2013 Timolol Maleate Sterile Ophthalmic Solution, USP 0.5%, 5mL, (NDC 16571-141-50... 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%, 10mL, (NDC 16571-130-11). The pro... 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 0.5%, 10mL, (NDC 16571-141-1... Defective Container: Stability samples of both products were noted to have some white solid produ... Class III PACK Pharmaceuticals, LLC
Sep 5, 2013 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 10 mL, Single-Dose Vial,... Lack of Assurance of Sterility; potential for vial breakage Class II Hospira Inc.
Aug 30, 2013 Aminosyn II, 10%, Sulfite-Free Amino Acid Injection, 500 mL container, Rx onl... Presence of Particulate Matter: Confirmed customer complaint of particulate matter, identified as... Class I Hospira Inc.
Aug 29, 2013 5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, R... Presence of Particulate Matter; report of visible particulates in the glass ampule Class II Hospira Inc.
Aug 23, 2013 Walgreens Progesterone in Ethyl Oleate 50 mg per mL Injection, 10 mL vial, In... Lack of Assurance of Sterility: Walgreens Specialty Pharmacy is recalling one lot of Progesterone... Class II Walgreens Co
Aug 16, 2013 Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic,... Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at ... Class II Hospira Inc.
Aug 14, 2013 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Unit... Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and c... Class II Hospira Inc.
Aug 12, 2013 Ketorolac Tromethamine Inj., USP, 30 mg vial, Rx only, Hospira, Inc., Lake Fo... Lack of Assurance of Sterility: Either a loose crimp or no crimp was applied to the fliptop vials. Class II Hospira, Inc.
Aug 1, 2013 Benztropine Mesylate Injection, USP, 2 mg/mL(1 mg/1 mL), 2 mL Single Dose Via... Presence of particulate matter: characterized as thin colorless flakes that are visually and chem... Class II Nexus Pharmaceuticals Inc
Aug 1, 2013 Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by ... Labeling: Incorrect Package Insert; product packaged with outdated version of the insert Class III AbbVie Inc.
Jul 24, 2013 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextro... Defective Container: There is a potential for frangible components to be broken, resulting in a l... Class II Baxter Healthcare Corp.
Jul 12, 2013 0.75% Bupivacaine HCl Injection, USP, 7.5 mg/mL, 30 mL, Single-dose, Hospira ... Presence of particulate matter: visible free floating and partially embedded particulate matter i... Class I Hospira Inc.
Jul 12, 2013 0.25% Bupivacaine HCl Injection, USP, 2.5 mg/mL, 30 mL, Single-dose, Hospira ... Presence of particulate matter: visible free floating and partially embedded particulate matter i... Class I Hospira Inc.
Jul 1, 2013 Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose ... Presence of particulate matter: characterized as thin colorless flakes that are visually and che... Class II Fresenius Kabi USA, LLC
Jun 27, 2013 Sodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial,... Presence of Particulate Matter: Confirmed customer report of visible particulate in the form of a... Class II Hospira Inc.
Jun 24, 2013 Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM ... Subpotent Drug; 15-month stability test station Class II Fresenius Kabi USA, LLC
Jun 19, 2013 AmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial,... Lack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on cert... Class II Astellas Pharma US Inc
Jun 7, 2013 VECURONIUM Bromide for Injection, 10 mg* per vial, *1 mg per mL when reconsti... CGMP Deviations: product was not manufactured under current good manufacturing practices which co... Class II Sagent Pharmaceuticals Inc
Jun 6, 2013 0.9% Sodium Chloride Injection, USP, 250 mL single dose Flexible Plastic Cont... Lack of Assurance of Sterility: The product has the potential for solution to leak at or near the... Class II Hospira Inc.
May 25, 2013 Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 ... Presence of Particulate Matter: Glass particulate matter was observed in a retention sample durin... Class I Fresenius Kabi USA, LLC
May 25, 2013 Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 mL, Single patie... Presence of Particulate Matter; single visible particulate was identified during a retain sample ... Class II Hospira Inc.
May 21, 2013 Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 20... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 21, 2013 0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (ND... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 21, 2013 Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Bax... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 21, 2013 5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only,... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 21, 2013 Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dos... Failed Impurities/Degradation Specification Class III Fresenius Kabi USA, LLC
May 21, 2013 Lidocaine Hydrochloride and 5% Dextrose Injection, USP, 2g VIAFLEX Plus Plast... Lack of Assurance of Sterilty: Specific lot numbers of these products have been identified for po... Class II Baxter Healthcare Corp.
May 21, 2013 Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Cont... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 20, 2013 Ondansetron Injection, USP, 4mg/2mL, (2mg/ml), 2mL single-dose Fliptop Vial, ... Presence of Particulate; lot being recalled as a precaution due to the discovery of 2 particles f... Class II Hospira, Inc.
May 16, 2013 Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, ... Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class II Hospira Inc.
May 15, 2013 Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit... Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an ... Class III Mylan Institutional, Inc. (d.b.a. UDL Laborator...
May 2, 2013 Gentamicin Sulfate Injection USP 80 mg/2 mL(40 mg/mL as Gentamicin), 2 mL Sin... Presence of Particulate Matter: visible particles were identified floating in the primary container. Class II Hospira 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.