CLASS II Drug recall · Reported 24 May 2023 · FDA Enforcement Report

Heparin Sodium, 25,000 USP units recalled by B. Braun Medical

B. Braun Medical is recalling Heparin Sodium, 25,000 USP units per, (100 USP units per mL) in 5% Dextrose injection, distributed nationwide in the US. The recall was initiated on 9 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number: J1P154N, Exp: 31 May, 2023,

NDC0264-9567, 0264-9577, 0264-9587

Quantity recalled1,380

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-0579-2023
FDA event ID: 92292
Recalling firm: B. Braun Medical, Irvine, CA
Brand: Heparin Sodium In Dextrose
Manufacturer: B. Braun Medical Inc.
Classification: Class II
Status: Terminated
Recall initiated: 9 May 2023
FDA classified: 16 May 2023
Reported: 24 May 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Thinners

Timeline

9 May 2023	Recall initiated by company
16 May 2023	Classified by FDA	+7 days
24 May 2023	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Subpotent: Low anti-factor IIa Potency.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dextrose injection, 250 ml Excel Container, B. Braun Medical Inc. Bethlehem, PA 18018, USA; API from Spain NDC: 0264-9587-20,

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Subpotent: Low anti-factor IIa Potency.

Which lots are affected?

Lot Number: J1P154N, Exp: 31 May, 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 26 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 B. Braun Medical

All 447

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9 Sep 2026Device	CLASS II	Extension Set Discofix Four Way Stopcock recalled by B Braun Medical	B Braun Medical	Other	Nationwide
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10 Jun 2026Device	CLASS I	Design Options Spinal Tray Spinal Needle Anesthesia recalled	B Braun Medical	Processing Deviation	Nationwide
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Other Heparin recalls

All 22

Reported	Class	Recall	Company	Reason	Where
11 Sep 2024Drug	CLASS I	Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection) recalledHeparin Sodium In Sodium Chloride	Baxter Healthcare	Sterility	Nationwide
15 Mar 2023Drug	CLASS II	Heparin Sodium Injection, USP, 20,000 USP units per mL recalledHeparin Sodium	Sagent Pharmaceuticals	Other	Nationwide
15 Mar 2023Drug	CLASS II	Heparin Sodium, 25,000USP units recalled by B. Braun MedicalHeparin Sodium In Dextrose	B. Braun Medical	Potency & Assay	Nationwide
1 Feb 2023Drug	CLASS II	Heparin/lido HCL/sodium Bicarb 100u/2mg/16.8mg/ML Syringe) recalled	Pharmacy Innovations	Sterility	Nationwide
11 Jan 2023Drug	CLASS II	Heparin Sodium 2,000, USP Units, per (2 USP Units/mL) recalled by PfizerHeparin Sodium	Pfizer	Sterility	Nationwide