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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 17, 2015 | fentaNYL Citrate, 25 mcg 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 | neostigmine Methylsulfate, 1 mg per mL, 2 mg per 2 mL, 2 mL Total Volume in a... | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... | Class II | Pharmedium Services, LLC |
| Jul 17, 2015 | Fentanyl Citrate 16.67 mcg per mL and Bupivacaine HCl 0.1667% in 0.9% Sodium ... | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... | Class II | Pharmedium Services, LLC |
| Jul 17, 2015 | lidocaine HCl, 2%, 20 mg per mL (100 mg per 5 mL), 5 mL Total Volume in a syr... | 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, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free (... | 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 17, 2015 | midazolam HCl, 1 mg per mL (2 mg per 2 mL), in 0.9% Sodium Chloride, 2 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, 0.5 mg per mL, in 0.9% Sodium Chloride, Preservative Free, ... | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... | Class II | Pharmedium Services, LLC |
| Jul 17, 2015 | Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a sy... | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... | Class II | Pharmedium Services, LLC |
| Jul 17, 2015 | lidocaine HCl, 1%, 10 mg per 1 mL, 1 mL Total Volume in a syringe, Rx only, P... | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... | Class II | Pharmedium Services, LLC |
| Jul 17, 2015 | glycopyrrolate, 0.2 mg per mL, 0.6 mg per 3 mL, 3 mL Total Volume in a syring... | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... | Class II | Pharmedium Services, LLC |
| Jul 17, 2015 | lidocaine HCl, 1%, 10 mg per mL (50 mg per 5 mL), 5 mL Total Volume in a syri... | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... | Class II | Pharmedium Services, LLC |
| Jul 17, 2015 | midazolam HCl, 1 mg per mL, in 0.9% Sodium Chloride, 1 mL Total Volume in a s... | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... | Class II | Pharmedium Services, LLC |
| Jul 17, 2015 | succinylcholine Chloride Injection, 20 mg per mL, 100 mg per 5 mL, 5 mL Total... | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... | Class II | Pharmedium Services, LLC |
| Jul 17, 2015 | fentaNYL Citrate, 5 mcg per mL, 15 mcg per 3mL, in 0.9% Sodium chloride, 3 mL... | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... | Class II | Pharmedium Services, LLC |
| Jul 17, 2015 | fentaNYL Citrate, 10 mcg per 1 mL, in 0.9% Sodium Chloride, Preservative Free... | Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in... | Class II | Pharmedium Services, LLC |
| 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. |
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.