Hospira Inc.: 149 FDA recall reports
Every drug recall the FDA has published for Hospira Inc.. The fault, and how the agency graded it.
149Reports
35Class I
10Ongoing
2017-05-31Most recent
35 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Class I
Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx on
D-0862-2017 · Class I · reported 2017-05-31 · Ongoing
- Why it was recalled
- Presence of Particulate Matter: human hair found within an internal sample syringe.
- Product
- Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 71,550 syringes
5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal A
D-0169-2017 · Class III · reported 2016-12-14 · Terminated
- Why it was recalled
- Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
- Product
- 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Single-dose ampule, 5 count box, Rx Only, For Spinal Anesthesia Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01
- Where it went
- US and Puerto Rico
- How much
- 287,200 2 mL ampules
Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake F
D-0153-2017 · Class II · reported 2016-11-30 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
- Product
- Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32
- Where it went
- Nationwide
- How much
- 797,800 ampules
DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg pe
D-1500-2016 · Class II · reported 2016-09-21 · Terminated
- Why it was recalled
- Discoloration: Firm received complaints of product discoloration and particulates.
- Product
- DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20
- Where it went
- Product was distributed nationwide. 23700 units distributed to US and Puerto Rico, and Bahamas was 300 units. 30 units returned by customer and destroyed internally.
- How much
- 24000 vials
Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-3
D-1359-2016 · Class II · reported 2016-07-20 · Terminated
- Why it was recalled
- Crystallization: Product contains particulate identified to be crystallized active ingredient.
- Product
- Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32
- Where it went
- Nationwide
- How much
- 373,850 tubes
Class I
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged
D-1137-2016 · Class I · reported 2016-07-13 · Ongoing
- Why it was recalled
- Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
- Product
- Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
- Where it went
- Nationwide, United Arab Emirates, Kuwait, and Bahrain
- How much
- 88,500 vials
Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-65
D-1033-2016 · Class II · reported 2016-06-22 · Terminated
- Why it was recalled
- Presence of Particulate Matter: Cardboard
- Product
- Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01
- Where it went
- Nationwide
Class I
8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lak
D-0865-2016 · Class I · reported 2016-06-01 · Ongoing
- Why it was recalled
- Presence of Particulate Matter: particulate matter identified as an insect in one vial.
- Product
- 8.4% Sodium Bicarbonate Injection, USP 50mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50 mL, Rx only, Hospira Inc, Lake Forest, IL 60045, NDC 0409-6625-02
- Where it went
- Nationwide
- How much
- 72,000 units
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged
D-0854-2016 · Class III · reported 2016-05-25 · Ongoing
- Why it was recalled
- Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
- Product
- Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
- Where it went
- Nationwide, Puerto Rico, United Arab Emirates, Israel, Kuwait, Bahrain, and Trinidad & Tobago
- How much
- 715,200 vials
Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 2
D-0836-2016 · Class III · reported 2016-05-11 · Ongoing
- Why it was recalled
- Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for the lot number and/or expiration date to be faded or missing from the primary label on the glass vial.
- Product
- Quelicin (Succinylcholine Chloride) Injection, USP 200 mg. (20 mg/mL), 10 mL Multiple-dose vial, packaged in 25 Unit vials per carton, Rx only, HOSPIRA, INC., LAKE FOREST, IL 60045 USA, NDC 0409-6629-02
- Where it went
- Nationwide
- How much
- 103,600 vials
Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 600
D-0829-2016 · Class II · reported 2016-04-27 · Terminated
- Why it was recalled
- Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- Product
- Dextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7935-19, Barcode (01) 0 030409 793519 2
- Where it went
- US: Nationwide and Singapore
- How much
- 552 bags
Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 6004
D-0831-2016 · Class II · reported 2016-04-27 · Terminated
- Why it was recalled
- Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- Product
- Mannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2
- Where it went
- US: Nationwide and Singapore
- How much
- 22292 bags
Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 6004
D-0828-2016 · Class II · reported 2016-04-27 · Terminated
- Why it was recalled
- Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- Product
- Dextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7936-19, Barcode (01) 0 030409 793619 9
- Where it went
- US: Nationwide and Singapore
- How much
- 4368 bags
Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 600
D-0827-2016 · Class II · reported 2016-04-27 · Terminated
- Why it was recalled
- Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- Product
- Dextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7918-19, Barcode (01) 0 030409 791819 5
- Where it went
- US: Nationwide and Singapore
- How much
- 11256 bags
Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, I
D-0832-2016 · Class II · reported 2016-04-27 · Terminated
- Why it was recalled
- Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- Product
- Potassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14
- Where it went
- US: Nationwide and Singapore
- How much
- 81888 bags
Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0
D-0830-2016 · Class II · reported 2016-04-27 · Terminated
- Why it was recalled
- Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- Product
- Aminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5
- Where it went
- US: Nationwide and Singapore
- How much
- 1776 bags
Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose
D-0727-2016 · Class III · reported 2016-03-02 · Ongoing
- Why it was recalled
- Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017".
- Product
- Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0.
- Where it went
- Nationwide and Hong Kong
- How much
- 10,778 bags
Class I
Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container
D-0668-2016 · Class I · reported 2016-02-24 · Terminated
- Why it was recalled
- Labeling: Incorrect Barcode: Primary bag labeling may be mislabeled with the wrong barcode which scans in as heparin sodium.
- Product
- Magnesium Sulfate in Water for Injection, (0.325 mEq Mg++/mL) 40 mg/mL, 2 g Total, 50 mL Single-Dose Container bag, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6729-24.
- Where it went
- Nationwide
- How much
- 213,600 bags
Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male
D-0054-2016 · Class III · reported 2015-10-28 · Ongoing
- Why it was recalled
- Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
- Product
- Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-8060-29
- Where it went
- Nationwide
- How much
- 24,100 Syringes
1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc.,
D-1815-2015 · Class II · reported 2015-09-30 · Ongoing
- Why it was recalled
- Presence of Particulate Matter: particulate matter identified as iron oxide, was found embedded in the neck of glass vials.
- Product
- 1% Lidocaine HCl Injection, USP, 10 mg/mL, 30 mL Vial, Single-dose Preservative Free, Rx only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-4279-02
- Where it went
- Nationwide
- How much
- 100,200 Vials
Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials pe
D-0418-2015 · Class II · reported 2015-09-23 · Terminated
- Why it was recalled
- Defective Container: There were customer complaints of cracked and leaking glass vials.
- Product
- Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05
- Where it went
- Nationwide
- How much
- 83,320 vials
KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc.,
D-1241-2015 · Class II · reported 2015-07-22 · Ongoing
- Why it was recalled
- Crystallization; identified as calcium salt of Ketorolac
- Product
- KETOROLAC Tromethamine Inj., USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3795-01 --- Also labeled under NOVAPLUS label NDC 0409-3795-49
- Where it went
- Nationwide, Puerto Rico, Guam, Canada and Singapore
- How much
- 12,460,975 vials(Hospira label); 3,016,500 vials (NOVAPLUS label)
KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc.,
D-1242-2015 · Class II · reported 2015-07-22 · Ongoing
- Why it was recalled
- Crystallization; identified as calcium salt of Ketorolac
- Product
- KETOROLAC Tromethamine Inj., USP, 60 mg (30 mg/mL), 2 mL Fill Single-dose Vials, I.V/I.M. USE, Hospira, Inc., Lake Forest, IL 60045 --- NDC 0409-3796-01 ---- ALSO labeled under NOVAPLUS label NDC 0409-3796-49
- Where it went
- Nationwide, Puerto Rico, Guam, Canada and Singapore
- How much
- 5,214,900 vials (Hospira label); 250,600 vials (NOVAPLUS label)
0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX
D-1240-2015 · Class II · reported 2015-07-22 · Terminated
- Why it was recalled
- Lack of assurance of sterility: Potential channel leaks near the threaded vial port.
- Product
- 0.9% Sodium Chloride Injection USP, 50 mL ADD-Vantage Unit, Rx only, Manufactured by Hospira, Inc., Ausitn, TX 78728, NDC 00409-7101-68
- Where it went
- United States
- How much
- 314600 bags
Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured
D-1232-2015 · Class III · reported 2015-07-15 · Terminated
- Why it was recalled
- Failed pH Specifications: 12 month stability testing
- Product
- Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02
- Where it went
- U.S. Nationwide, Kuwait, Bahrain and Israel.
- How much
- 106,900 vials
Class I
Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSP
D-1216-2015 · Class I · reported 2015-07-15 · Terminated
- Why it was recalled
- Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.
- Product
- Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.
- Where it went
- U.S. Nationwide including Guam.
- How much
- 150,950 Vials
Class I
LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lak
D-1108-2015 · Class I · reported 2015-06-03 · Terminated
- Why it was recalled
- Non-Sterility: Confirmed customer report of dark, fibrous particulates floating within the solution of the primary container, which were subsequently identified as mold
- Product
- LACTATED RINGER'S IRRIGATION, USP, 3000 mL flexible container bag, Rx Only, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7828-08.
- Where it went
- Nationwide
- How much
- 24,744 flexible container bags
Class I
MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL
D-1076-2015 · Class I · reported 2015-05-20 · Terminated
- Why it was recalled
- Labeling: Wrong Bar Code: There is a potential for some units to be mislabeled with an incorrect barcode on the immediate container that scans as heparin sodium 2000 USP units/1000 mL in 0.9% in sodium chloride injection.
- Product
- MAGNESIUM SULFATE IN 5% DEXTROSE INJECTION, USP, 10 mg/mL; 100 mL bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-6727-23, UPC (01) 0 030409 672723 1.
- Where it went
- Nationwide
- How much
- 181,704 bags
Class I
0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045,
D-0976-2015 · Class I · reported 2015-05-13 · Terminated
- Why it was recalled
- Presence of Particulate Matter: Confirmed finding of human hair floating in IV solution.
- Product
- 0.9% Sodium Chloride Injection, USP, 250 mL, Rx only, VisIV Container, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7983-25.
- Where it went
- Nationwide.
- How much
- 9,912 VisIV flex containers
Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Fo
D-0972-2015 · Class II · reported 2015-05-06 · Terminated
- Why it was recalled
- Crystallization
- Product
- Ketorolac Tromethamine Inj. USP, 30 mg (30 mg/mL), 1 mL Fill, Single-dose vial, Rx Only, Hospira Inc., Lake Forest, IL --- NDC 00409-3795-01--- Also labeled under NOVAPLUS label NDC 00409-3795-49
- Where it went
- Nationwide, Puerto Rico and Guam.
Showing the 30 most recent of 149. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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