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 30, 2014 | 0.9% Sodium Chloride Injection, USP, 500 mL, VIAFLEX Plastic Container, Baxte... | Lack of Assurance of Sterility; complaints of mold in the overpouch | Class II | Baxter Healthcare Corp. |
| Jul 29, 2014 | Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Singl... | Presence of Particulate Matter: The product was discolored and contained visible particulates (ir... | Class I | Hospira Inc. |
| Jul 11, 2014 | 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container ba... | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. | Class I | Baxter Healthcare Corp. |
| Jul 11, 2014 | Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Con... | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics | Class I | Baxter Healthcare Corp. |
| Jul 11, 2014 | 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Si... | Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. | Class I | Baxter Healthcare Corp. |
| Jul 10, 2014 | LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers... | Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of... | Class I | Hospira Inc. |
| Jul 3, 2014 | Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules... | Failed Impurities/Degradation Specifications: High out-of-specification results for a related com... | Class III | Mylan Institutional, Inc. (d.b.a. UDL Laborator... |
| Jun 27, 2014 | Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, C-II, (50 mcg/mL), ... | Lack of Assurance of Sterility: Fliptop vial crimps are loose or missing. | Class II | Hospira Inc. |
| Jun 17, 2014 | Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (15... | Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible ... | Class I | Hospira Inc. |
| Jun 16, 2014 | Brevibloc Premixed Injection, Esmolol Hydrochloride in Sodium Chloride, 2,500... | Presence of Particulate Matter: Complaints received of discolored solution identified as subvisib... | Class II | Baxter Healthcare Corp. |
| Jun 6, 2014 | Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/25... | Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container... | Class II | Hospira Inc. |
| May 16, 2014 | Labetalol Hydrochloride Injection, USP, 100 mg/20 mL (5 mg/mL), 20 mL Multido... | Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating i... | Class II | Hospira Inc. |
| May 12, 2014 | 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, B... | Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes | Class I | Baxter Healthcare Corp. |
| May 2, 2014 | Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= pheny... | Presence of Particular Matter: Potential glass delamination and consistent with glass particulate... | Class II | Fresenius Kabi USA, LLC |
| May 2, 2014 | Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenyto... | Presence of Particular Matter: Potential glass delamination and consistent with glass particulate... | Class II | Fresenius Kabi USA, LLC |
| Apr 24, 2014 | Famotidine Injection 20 mg, Rx Only, GALAXY Single Dose Container, Code 2G342... | Presence of Particulate Matter: Baxter Healthcare Corporation has received a complaint reporting ... | Class II | Baxter Healthcare Corp. |
| 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 |
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.