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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
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.
Apr 30, 2013 DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL ba... Lack of Assurance of Sterility: Confirmed report of leaking in the primary container. Class II Hospira Inc.
Apr 8, 2013 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patie... Presence of Particulate Matter: A single visible particulate was identified during a retain sampl... Class II Hospira Inc.
Apr 1, 2013 ROCK-IT MAN capsules, male sexual stimulant, packaged in 1-count (UPC 8 53447... Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain hydroxythiohomos... Class I Consumer Concepts, Inc.
Mar 29, 2013 0.9% Sodium Chloride Injection, USP, 1000 mL flexible container, Rx only, Hos... Presence of Particulate Matter: reports of small grey/brown particles found in the primary contai... Class I Hospira Inc.
Mar 21, 2013 Children's Acetaminophen Oral Suspension, 650 mg/20.3 mL unit dose cup (NDC 6... Labeling: Not Elsewhere Classified: This unit dose product is being recalled because the product'... Class II Precision Dose Inc.
Feb 27, 2013 0.9% Sodium Chloride Injection, USP, 50 mL Mini-Bag Plus Container, Rx only, ... Labeling Wrong Barcode; It may display wrong product code reflecting 0.9% Sodium Chloride Injec... Class II Baxter Healthcare Corp.
Feb 26, 2013 Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Flip... Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class II Hospira Inc.
Feb 26, 2013 QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, ... Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class II Hospira Inc.
Feb 26, 2013 Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx on... Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class II Hospira Inc.
Feb 26, 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.
Feb 25, 2013 Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient inf... Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed ... Class II Hospira Inc.
Feb 18, 2013 0.9% Sodium Chloride Injection, USP, 50 mL, Manufactured by Hospira, Inc., La... Lack of Assurance of Sterility: The product is being recall due to the product lot being incorrec... Class II Hospira Inc.
Feb 15, 2013 METRONIDazole Injection, USP 500 mg (5 mg/mL), 100 mL Bag, Rx only, Hospira,... Lack of Assurance of Sterility: There is the potential for the solution to leak from the administ... Class II Hospira Inc.
Feb 12, 2013 0.9% Sodium Chloride Irrigation, USP, 3000 mL, Sterile, Non pyrogenic, Rx Onl... Lack of Assurance of Sterility: There is a potential for the solution to leak from the administra... Class II Hospira Inc.
Feb 1, 2013 CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, R... Labeling: Missing label Class III Fresenius Kabi USA LLC (FK USA)
Jan 25, 2013 Lactated Ringer's and 5% Dextrose Injection, USP, 1000 mL flexible container,... Non-Sterility: Confirmed customer complaint of product contaminated with mold. Class I 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.