thejoe Levofloxacin

Levofloxacin recalls: 7 FDA reports

Recalls involving Levofloxacin. What was wrong with each batch, and how the FDA graded the risk.

7Reports

0Class I

0Ongoing

2022-06-15Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class III	4
Class II	3

By year reported

Year	Reports
2017	1
2018	4
2021	1
2022	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61

D-1088-2022 · Class II · reported 2022-06-15 · Terminated

Why it was recalled: cGMP deviations: Temperature abuse
Product: Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61
Where it went: USA nationwide.
How much: 1 box/100 blisters packs per box

Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible C

D-0494-2021 · Class II · reported 2021-06-02 · Terminated

Why it was recalled: CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Product: Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers NDC 0143-9721-24 West-Ward Pharmaceutical Corp Eatontown, NJ 07724 USA
Where it went: FL, GA, SC
How much: 35 bags

Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-

D-1215-2018 · Class III · reported 2018-10-03 · Terminated

Why it was recalled: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Product: Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.
Where it went: Nationwide USA and Puerto Rico
How much: 523,896 bags

Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Contain

D-1034-2018 · Class III · reported 2018-08-15 · Terminated

Why it was recalled: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Product: 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 went: Nationwide USA and Puerto Rico
How much: 191,256 bags

Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Conta

D-1036-2018 · Class III · reported 2018-08-15 · Terminated

Why it was recalled: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Product: Levofloxacin Injection in 5% Dextrose, 750 mg (5 mg/mL), 750 mg in 150 mL 5% Dextrose, 150 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-048-24.
Where it went: Nationwide USA and Puerto Rico
How much: 711,216 bags

Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Conta

D-1035-2018 · Class III · reported 2018-08-15 · Terminated

Why it was recalled: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Product: Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24.
Where it went: Nationwide USA and Puerto Rico
How much: 106,320 bags

Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesc

D-0615-2017 · Class II · reported 2017-04-05 · Terminated

Why it was recalled: Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Product: Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24
Where it went: Nationwide
How much: 24,456 units (1019 cartons x 24 bags)

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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