CLASS III Drug recall · Reported 15 Aug 2018 · FDA Enforcement Report

Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL) recalled

Baxter Healthcare is recalling Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 5% Dextrose Single Use, distributed nationwide in the US. The recall was initiated on 1 Aug 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: A061178, A061183, A061236, Exp 09/18; A0A0937, Exp 08/19; A0A1044, A0A1048, Exp 10/19

NDC36000-045, 36000-046, 36000-047, 36000-048

UPC0336000047241, 0336000045018, 0336000046244

Quantity recalled191,256 bags

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-1034-2018
FDA event ID: 80653
Recalling firm: Baxter Healthcare, Deerfield, IL
Brand: Levofloxacin
Manufacturer: Baxter Healthcare Corporation
Classification: Class III
Status: Terminated
Recall initiated: 1 Aug 2018
FDA classified: 3 Aug 2018
Reported: 15 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Antibiotics

Timeline

1 Aug 2018	Recall initiated by company
3 Aug 2018	Classified by FDA	+2 days
15 Aug 2018	Published in enforcement report	+12 days

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

Reason for recall

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

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

Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.

Where it was distributed

Nationwide USA and Puerto Rico

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.

Which lots are affected?

Lot #: A061178, A061183, A061236, Exp 09/18; A0A0937, Exp 08/19; A0A1044, A0A1048, Exp 10/19

Where was it sold?

Nationwide USA and Puerto Rico

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

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.

Other products in this recall event

2 other products · FDA event 80653

Reported	Class	Recall	Company	Reason	Where
15 Aug 2018	CLASS III	Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL) recalledLevofloxacin	Baxter Healthcare	Potency & Assay	Nationwide
15 Aug 2018	CLASS III	Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL) recalledLevofloxacin	Baxter Healthcare	Potency & Assay	Nationwide

More recalls from Baxter Healthcare

All 570

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Drug	CLASS I	Dextrose Injection, USP, 70 % recalled by Baxter Healthcare	Baxter Healthcare	Particulate Matter	Nationwide
9 Sep 2026Drug	CLASS I	0.9% Sodium Chloride Injection USP, Viaflex recalledSodium Chloride	Baxter Healthcare	Particulate Matter	IL
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare	Baxter Healthcare	Device Malfunction	Nationwide
9 Sep 2026Drug	CLASS II	Clindamycin Phosphate in 0.9% Sodium Chloride Injection recalledClindamycin Phosphate	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide

Other Levofloxacin recalls

All 19

Reported	Class	Recall	Company	Reason	Where
7 Jun 2023Drug	CLASS II	Levofloxacin Oral Solution, 25 mg/mL recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Levofloxacin Ophthalmic Solution recalled by Akorn	Akorn	Potency & Assay	Nationwide
7 Jun 2023Drug	CLASS II	Levofloxacin Injection 500mg/ (25 mg/mL), For Intravenous Infusion recalled	Akorn	Potency & Assay	Nationwide
25 Jan 2023Drug	CLASS III	Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa	Macleods Pharma USA	Packaging Defects	Nationwide
15 Jun 2022Drug	CLASS II	Levofloxacin Tablets, 500 mg unit dose recalledLevofloxacin	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide