CLASS II Drug recall · Reported 11 Jan 2023 · FDA Enforcement Report
Heparin Sodium 2,000, USP Units, per (2 USP Units/mL) recalled by Pfizer
Pfizer is recalling Heparin Sodium 2,000, USP Units, per (2 USP Units/mL) in 9% Sodium Chloride Injection, a), distributed nationwide in the US. The recall was initiated on 29 Dec 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0097-2023
- FDA event ID
- 91379
- Recalling firm
- Pfizer, New York, NY
- Brand
- Heparin Sodium
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 29 Dec 2022
- FDA classified
- 5 Jan 2023
- Reported
- 11 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Blood Thinners
Timeline
| 29 Dec 2022 | Recall initiated by company | |
| 5 Jan 2023 | Classified by FDA | +7 days |
| 11 Jan 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of assurance of sterility: Bags have the potential to leak.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,
Where it was distributed
Nationwide in the USA.
Questions about this recall
Is Heparin Sodium 2,000, USP Units, per (2 USP Units/mL) in 9% Sodium Chloride Injection, a) recalled?
Yes. Pfizer recalled Heparin Sodium 2,000, USP Units, per (2 USP Units/mL) in 9% Sodium Chloride Injection, a) on 29 Dec 2022. The recall is Class II and its status is Completed. Recall number D-0097-2023.
Why was it recalled?
Lack of assurance of sterility: Bags have the potential to leak.
Which lots are affected?
Lot: 5935283, Exp. 12/01/2023
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pfizer
All 126| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Vial Label: 4% Sodium Bicarbonate Injection, USP, 50mEq/ (1 mEq/mL) recalledSodium Bicarbonate | PFIZER | Sterility | Nationwide |
| Drug | CLASS II | Vial Label: Epinephrine Injection, USP, 1mg/ 1 mg/mL) recalled by PFIZER | PFIZER | Sterility | Nationwide |
| Drug | CLASS II | Levoxyl (levothyroxine sodium tablets, USP), 50 mcg recalled by PfizerLevoxyl | Pfizer | Potency & Assay | NY |
| Drug | CLASS II | Bicillin L-A (penicillin G benzathine injectable recalled by PfizerBicillin L-a | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | Bicillin L-A (penicllin G benzathine injectable suspension) per-vial recalledBicillin L-a | Pfizer | Particulate Matter | Nationwide |
Other Heparin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Heparin (Heparin Sodium in 9% Sodium Chloride Injection) recalledHeparin Sodium In Sodium Chloride | Baxter Healthcare | Sterility | Nationwide |
| Drug | CLASS II | Heparin Sodium Injection, USP, 20,000 USP units per mL recalledHeparin Sodium | Sagent Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Heparin injection, Preservative Free, a), b) syringe, c) recalled | Walgreens Infusion Services | Sterility | TX |
| Drug | CLASS I | Heparin Sodium Injection USP 25,000 USP Units added to recalled | Pharmedium Services | Particulate Matter | Nationwide |
| Drug | CLASS I | Heparin Sodium Injection recalled by Pharmedium Services | Pharmedium Services | Particulate Matter | Nationwide |