CLASS I Drug recall · Reported 19 Oct 2016 · FDA Enforcement Report

5% Dextrose Injection USP in a PAB container recalled

B. Braun Medical is recalling 5% Dextrose Injection USP in a PAB container, distributed nationwide in the US. The recall was initiated on 25 Mar 2016 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot #: J5J706, Exp. 10/31/2016

Quantity recalled57,408 units

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-0094-2017
FDA event ID: 73626
Recalling firm: B. Braun Medical, Irvine, CA
Classification: Class I
Status: Terminated
Recall initiated: 25 Mar 2016
FDA classified: 12 Oct 2016
Reported: 19 Oct 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Injectable & IV Drugs

Timeline

25 Mar 2016	Recall initiated by company
12 Oct 2016	Classified by FDA	+201 days
19 Oct 2016	Published in enforcement report	+7 days

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

Reason for recall

Non-Sterility: fungal contamination due to leaking containers.

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

5% Dextrose Injection USP, 100mL in a 150 mL PAB container, Rx only, B. Braun Medical Inc. Irvine, CA 92614-5895 USA, NDC 00264-1510-32

Where it was distributed

Nationwide

Questions about this recall

Why was it recalled?

Non-Sterility: fungal contamination due to leaking containers.

Which lots are affected?

Lot #: J5J706, Exp. 10/31/2016

Where was it sold?

Nationwide

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection, USP Partial Fill recalledSodium Chloride	B Braun Medical	Particulate Matter	Nationwide
9 Sep 2026Device	CLASS II	Extension Set Discofix Four Way Stopcock recalled by B Braun Medical	B Braun Medical	Other	Nationwide
2 Sep 2026Drug	CLASS I	Lactated Ringer's Injection USP Excel container recalledLactated Ringers	B Braun Medical	Particulate Matter	Nationwide
10 Jun 2026Device	CLASS I	Design Options Spinal Tray Spinal Needle Anesthesia recalled	B Braun Medical	Processing Deviation	Nationwide
10 Jun 2026Device	CLASS II	Sesk Upmc Double Catheter Tray recalled by B Braun Medical	B Braun Medical	Device Malfunction	Nationwide

Other Dextrose recalls

All 44

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	Dextrose Injection, USP, 70 % recalled by Baxter Healthcare	Baxter Healthcare	Particulate Matter	Nationwide
29 Apr 2026Drug	CLASS II	Dextrose Injection recalled by B Braun MedicalDextrose	B Braun Medical	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose	Fresenius Kabi USA	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	5% Dextrose Injection, USP per (50 mg per mL) in a freeflex recalledDextrose	Fresenius Kabi USA	Sterility	Nationwide