Stop using now Drug recall · FDA · Published December 29, 2022

Pfizer Heparin Sodium 2000 Units Recall: Potential Leakage Risk

Pfizer recalls Heparin Sodium 2,000 units per 1,000 mL bags due to potential leakage. This may cause contamination. Check your product details to see if affected.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0097-2023Drug Pfizer ›

Stop using this now

Lack of assurance of sterility: Bags have the potential to leak.

Take action

Contact the company

Recalling firmPfizer Inc.235 East 42nd Street · New York, NY 10017-5703

✎ GovInfoNow plain-language explainer

Pfizer is recalling Heparin Sodium 2,000 units per 1,000 mL bags because they may leak, risking contamination. This is a serious issue for medical use. Read more at govinfonow.com/recall/34042-pfizer-heparin-sodium-2000-units-recall-potential-leakage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/34042-pfizer-heparin-sodium-2000-units-recall-potential-leakage-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0097-2023

Cite this page

“Pfizer Heparin Sodium 2000 Units Recall: Potential Leakage Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/34042-pfizer-heparin-sodium-2000-units-recall-potential-leakage-risk. Based on FDA recall #D-0097-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0097-2023%22&limit=1).

Pfizer Inc. recalled Heparin Sodium Injection bags due to potential leaks that compromise sterility assurance, according to the FDA on December 29, 2022.

How to tell if you have it

Brand: Pfizer
Product: Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags
NDC: 0409-7620-59 (Case), 0409-7620-49 (Single Unit)
Lot: 5935283
Expiration: 12/01/2023
Distributed by: Hospira, Inc., Lake Forest, IL 60045 USA
Quantity: 62,088 bags

The hazard

The recall addresses a lack of assurance of sterility because the bags have the potential to leak.

Context

GovInfoNow's records show Pfizer Inc. has 71 other recalls on record since 2012-11-26. Other recent recalls include Pfizer Sodium Bicarbonate Injection due to lack of sterility assurance (2025-08-04) and Pfizer Bicillin L-A Injectable Suspension for particulate risk (2025-07-10). Similar recent recalls of sterile saline or IV products include B Braun 3000mL Sterile Saline Bags (2026-04-02), Otsuka ICU Medical 100mL IV Fluid (2025-10-27), and OneSource Specialty Pharma Methohexital Sodium (2026-06-07).

How to tell if you have this one

Check for the product name 'Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags'. Look for lot number 5935283.

Brand
Pfizer
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop Using Now
Immediately stop using the recalled heparin injection product as it may leak and cause contamination.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 13 days after the firm started it.

Dec 29, 2022Firm started the recall
Jan 5, 2023FDA classified it Class II
Jan 11, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Is this product safe to use?

No, the product may leak, so it should not be used. Contact Pfizer for further instructions.

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Link to this recall

<a href="https://govinfonow.com/recall/34042-pfizer-heparin-sodium-2000-units-recall-potential-leakage-risk">Pfizer Heparin Sodium 2000 Units Recall: Potential Leakage Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0097-2023 (December 29, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0097-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.