Hospira Inc.
Complete recall history across all FDA and CPSC categories — 245 total recalls
Recall Summary
Hospira Inc. appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (138)
FDA drug safety enforcement actions by Hospira Inc.. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Apr 21, 2017 | Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Sing... | Presence of Particulate Matter: human hair found within an internal sample sy... | Class I |
| Nov 1, 2016 | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/m... | Lack of Assurance of Sterility: Complaints of broken tips on the ampules. | Class II |
| Aug 15, 2016 | DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be ... | Discoloration: Firm received complaints of product discoloration and particul... | Class II |
| Jun 29, 2016 | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5... | Failed Stability Specifications: The recalled lots did not meet the specifica... | Class III |
| Jun 23, 2016 | Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake ... | Crystallization: Product contains particulate identified to be crystallized a... | Class II |
| May 6, 2016 | Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hosp... | Presence of Particulate Matter: Cardboard | Class II |
| Mar 23, 2016 | Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, ... | Failed pH Specifications: Confirmed high out of specification (OOS) results f... | Class III |
| Mar 23, 2016 | Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, ... | Presence of Particulate Matter: Confirmed customer complaint for the presence... | Class I |
| Mar 18, 2016 | 8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL),... | Presence of Particulate Matter: particulate matter identified as an insect i... | Class I |
| Mar 15, 2016 | Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot num... | Class III |
| Mar 8, 2016 | Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, In... | Chemical Contamination: Potential for contamination of the products with an a... | Class II |
| Mar 8, 2016 | Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx on... | Chemical Contamination: Potential for contamination of the products with an a... | Class II |
| Mar 8, 2016 | Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Ho... | Chemical Contamination: Potential for contamination of the products with an a... | Class II |
| Mar 8, 2016 | Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hos... | Chemical Contamination: Potential for contamination of the products with an a... | Class II |
| Mar 8, 2016 | Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hos... | Chemical Contamination: Potential for contamination of the products with an a... | Class II |
| Mar 8, 2016 | Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Ho... | Chemical Contamination: Potential for contamination of the products with an a... | Class II |
| Feb 2, 2016 | Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection ... | Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report... | Class III |
| Jan 5, 2016 | Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g T... | Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the ... | Class I |
| Sep 29, 2015 | Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL,... | Failed Impurities/Degradation Specifications: Out of Specification(OOS) resul... | Class III |
| Aug 20, 2015 | Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose... | Defective Container: There were customer complaints of cracked and leaking gl... | Class II |
| 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 via... | Class II |
| 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 |
| 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 |
| May 19, 2015 | Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV... | Failed pH Specifications: 12 month stability testing | Class III |
| 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 o... | Class I |
| Apr 13, 2015 | Ketorolac Tromethamine Inj. USP, 60 mg (30 mg/mL), 2 mL Fill, Single-dose via... | Crystallization | Class II |
| Apr 13, 2015 | Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose via... | Crystallization | Class II |
| 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 adm... | Class II |
| Mar 11, 2015 | LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, M... | Non-Sterility: Confirmed customer report of dark, fibrous particulates floati... | Class I |
| Mar 6, 2015 | MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx onl... | Labeling: Wrong Bar Code: There is a potential for some units to be mislabele... | Class I |
| Mar 5, 2015 | 5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), U... | Lack of Assurance of Sterility: there is a potential for solution to leak at ... | Class II |
| Mar 5, 2015 | 0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospi... | Presence of Particulate Matter: Confirmed finding of human hair floating in I... | Class I |
| Jan 23, 2015 | KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vi... | Crystallization | Class II |
| Jan 23, 2015 | KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Via... | Crystallization | Class II |
| Jan 20, 2015 | 0.9% Sodium Chloride Injection, USP, 250 mL, Rx Only, Hospira Inc., Lake Fore... | Presence of Particulate Matter; Hospira has identified the particulate as a h... | Class I |
| Dec 23, 2014 | Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single pati... | Presence of Particulate Matter: The firm received a complaint of an embedded ... | Class II |
| Dec 22, 2014 | 0.9% Sodium Chloride Injection, USP, 100mL, VisIV Container, Rx only, Hospira... | Lack of Assurance of Sterility: The product has the potential for solution to... | Class II |
| Dec 3, 2014 | Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose F... | Lack of Assurance of Sterility; improperly crimped fliptop vials | Class II |
| Dec 3, 2014 | MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake F... | Failed Stability Specifications: Product is subpotent and has out of specific... | Class I |
| Nov 25, 2014 | Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx... | Discoloration: Reconstituted solution may appear pink instead of colorless to... | Class III |
| Nov 7, 2014 | Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g... | Correct Labeled Product Mispack: Product tray containing vials was mislabeled... | Class III |
| Oct 24, 2014 | Meropenem I.V. 1 g is supplied in 30 mL injection vials, RX only. Manufactur... | Defective Container: Glass vials may crack due to low (thin) out of specifica... | Class II |
| Oct 16, 2014 | 1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Fr... | Presence of particulate matter: A returned customer sample was evaluated and ... | Class I |
| Oct 14, 2014 | Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1... | Lack of Assurance of Sterility: Potential of punctures through the overwrap a... | Class II |
| Oct 14, 2014 | Normosol-R pH 7.4 Multiple Electrolytes Injection Type 1, USP, 1000 mL contai... | Lack of Assurance of Sterility: Potential of punctures through the overwrap a... | Class II |
| Oct 14, 2014 | Normosol-R Multiple Electrolytes Injection Type 1, USP, 1000 mL container, R... | Lack of Assurance of Sterility: Potential of punctures through the overwrap a... | Class II |
| Oct 14, 2014 | Lactated Ringer's and 5% Dextrose Injection, USP; 1000 mL container, Rx Only,... | Lack of Assurance of Sterility: Potential of punctures through the overwrap a... | Class II |
| Oct 14, 2014 | Lactated Ringer's Injection, USP, 1000 mL container, Rx Only, Manufactured by... | Lack of Assurance of Sterility: Potential of punctures through the overwrap a... | Class II |
| Oct 14, 2014 | 5% Dextrose and 0.45% Sodium Chloride Injection, USP, 1000 mL container, Rx O... | Lack of Assurance of Sterility: Potential of punctures through the overwrap a... | Class II |
| Oct 14, 2014 | 5% Dextrose Injection, USP, 1000 mL container, Rx Only, Manufactured by Hospi... | Lack of Assurance of Sterility: Potential of punctures through the overwrap a... | Class II |
Device Recalls (107)
FDA medical device enforcement actions by Hospira Inc.. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Mar 25, 2016 | The Plum 360 is a large volume infuser capable of delivering fluids for a var... | Firm's investigation determined that the Proximal Occlusion Alarms observed i... | Class II |
| Mar 25, 2016 | The Plum A+ is a dual-line volumetric infusion system designed to meet the gr... | Firm's investigation determined that the Proximal Occlusion Alarms observed i... | Class II |
| Dec 22, 2015 | The Symbiq infusion pump is a device used in a health care facility to pump f... | Potential for the Symbiq pole clamp assemblies to be missing the rubber stop... | Class II |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may f... | Class I |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may f... | Class I |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may f... | Class I |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may f... | Class I |
| Jul 2, 2014 | The Plum A+ Infusion System is designed to meet the fluid delivery requiremen... | One lot of alarm assemblies used in Plum A+ and Plum A+3 infusion pumps may f... | Class I |
| Jun 11, 2014 | Plum A+ Infusion System with Hospira MedNet List 20792-04-25, Pole Clamp Asse... | Plum A+ infusion system pole clamp assemblies were discovered to be cracked. ... | Class II |
| Jun 6, 2014 | The Hospira MedNet Medication Management Suite (MMS). Product Usage: The ... | Hospira MedNet 5.5, 5.8.1, and 5.8.2 contains software defect where the dosin... | Class II |
| Mar 25, 2014 | LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Consta... | The Tyvek cover may not be completely sealed to the rest of the package allow... | Class II |
| Mar 25, 2014 | LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures... | The Tyvek cover may not be completely sealed to the rest of the package allow... | Class II |
| Mar 25, 2014 | LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); Fo... | The Tyvek cover may not be completely sealed to the rest of the package allow... | Class II |
| Mar 25, 2014 | LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compat... | The Tyvek cover may not be completely sealed to the rest of the package allow... | Class II |
| Mar 25, 2014 | LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Rese... | The Tyvek cover may not be completely sealed to the rest of the package allow... | Class II |
| Feb 25, 2014 | LifeShield LATEX-FREE HemoSet 100 mL Burette I.V. PlumSet, Nonvented, 105 inc... | Hospira identified an incorrect lower lid (set component) had been supplied a... | Class II |
| Feb 18, 2014 | GemStar Docking Station, used with GemStar infusion pump, in combination with... | There are two situations that may occur when using the GemStar Docking Statio... | Class I |
| Feb 3, 2014 | The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... | The GemStar Infusion pump may not receive direct current (DC) power from the ... | Class I |
| Feb 3, 2014 | The GemStar Power Supply is an accessory for the GemStar Infusion Pump. It is... | The GemStar Infusion pump may not receive direct current (DC) power from the ... | Class I |
| Jan 31, 2014 | GemStar infusion pump, List numbers 13000 and 13100, GemStar Infusion Pump (... | The connection between the beeper subassembly and the pump may fail. The GemS... | Class II |
| Jan 24, 2014 | LifeCare 5000 Pump (Plum 1.6) infusion pump, indicated for volumetric infusi... | There is the potential for the door roller assembly on the Plum LifeCare 5000... | Class II |
| Jan 24, 2014 | Plum XL3 Multi line Infusion System, Micro Macro Plum XL3 Multi line Infusion... | There is the potential for the door roller assembly on the Plum LifeCare 5000... | Class II |
| Jan 24, 2014 | Plum XL, Micro Macro Plum XL3 with data port, and Micro Macro Plum XL with d... | There is the potential for the door roller assembly on the Plum LifeCare 5000... | Class II |
| Oct 31, 2013 | Hospira Acclaim Encore Infusion Pump Designed to deliver parenteral infus... | Broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. ... | Class I |
| Oct 31, 2013 | Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions incl... | Hospira has received customer reports of broken door assemblies on the Hospir... | Class I |
| Oct 25, 2013 | *** 1) List number 126970465 labeled in part: 12697-65 LifeShield LATEX-FREE ... | Several lots of the LifeShield Latex-Free HEMA Y-Type Blood Set IV Administra... | Class II |
| Sep 10, 2013 | Hospira RECEPTAL CANISTERS: 1L(1000mL), 1.5L(1500mL), 2L(2000mL) Canister, A... | Hospira has become aware of customers using the incorrect size Receptal liner... | Class II |
| Sep 10, 2013 | Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) 1) List Nu... | Hospira has become aware of customers using the incorrect size Receptal liner... | Class II |
| Sep 9, 2013 | *** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200... | Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV ... | Class II |
| Sep 9, 2013 | *** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBL... | Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV ... | Class II |
| Sep 9, 2013 | *** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BL... | Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV ... | Class II |
| Sep 9, 2013 | *** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH ... | Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV ... | Class II |
| Sep 9, 2013 | *** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE P... | Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV ... | Class II |
| Aug 28, 2013 | *** 1) SYMBIQ One-Channel Infuser; *** 2) SYMBIQ Two-Channel Infuser; **... | Hospira shipped the incorrect replaceable battery pack (Part No: HSP3566-E10)... | Class II |
| Jul 17, 2013 | Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 90... | Hospira has recieved reports that the vacuum needed to create suction with th... | Class II |
| Jun 18, 2013 | LifeShield; Sterile; Rx only; List No. 19666-28; SYMBIQ PUMP SET, CONVERTIBLE... | Hospira has received reports of customers experiencing air-in-line alarms rel... | Class II |
| Apr 1, 2013 | List No. 14207-28; BLOOD SET; 200 Micron Filter, 105 Inch, Non-DEHP; For Bloo... | It was discovered that there was a potential for the piercing pin on certain ... | Class I |
| Apr 1, 2013 | List No. 14211-28; PLUM BLOOD SET; Prepierced Port, 200 Micron Filter, 110 In... | It was discovered that there was a potential for the piercing pin on certain ... | Class I |
| Apr 1, 2013 | List No. 14200-28; SECONDARY BLOOD SET; 200 Micron Filter, 36 Inch, Non-DEHP;... | It was discovered that there was a potential for the piercing pin on certain ... | Class I |
| Apr 1, 2013 | List No. 14217-28; Y-TYPE BLOOD SET; 200 Micron Filter, Prepierced Y-Site, No... | It was discovered that there was a potential for the piercing pin on certain ... | Class I |
| Apr 1, 2013 | List No. 14219-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, CLAVE ... | It was discovered that there was a potential for the piercing pin on certain ... | Class I |
| Apr 1, 2013 | List No. 14206-28; Y-TYPE BLOOD SET; 200 Micron Filter, Cylinder Pump, Conver... | It was discovered that there was a potential for the piercing pin on certain ... | Class I |
| Apr 1, 2013 | List No. 14210-28; PLUM BLOOD SET; 100 mL Burette with Prepierced Injection S... | It was discovered that there was a potential for the piercing pin on certain ... | Class I |
| Apr 1, 2013 | List No. 14212-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-... | It was discovered that there was a potential for the piercing pin on certain ... | Class I |
| Apr 1, 2013 | List No. 14203-28; BLOOD SET; 200 Micron Filter, 80 Inch, Non-DEHP; For Blood... | It was discovered that there was a potential for the piercing pin on certain ... | Class I |
| Mar 21, 2013 | The GemStar Pump is a small and lightweight, single channel infusion device d... | During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturi... | Class II |
| Mar 21, 2013 | The GemStar Pump is a small and lightweight, single channel infusion device d... | During infusions of 2.0 mL/hr the motor assembly may rotate backwards capturi... | Class II |
| Mar 19, 2013 | GemStar infusion pump, list numbers 13086 and 13087, GemStar infusion pump (p... | Some patients are obtaining access to the dosage reset codes required to chan... | Class II |
| Mar 19, 2013 | GemStar infusion pump, list numbers 13000 and 13100, GemStar Infusion Pump (p... | Some patients are obtaining access to the dosage reset codes required to chan... | Class II |
| Mar 18, 2013 | GemStar Pump - Battery Product Usage: The GemStar Pump is a small and li... | Battery level lower then 2.4 volts results in corrupt history log and loss of... | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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