Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated Oct 13, 2022 (4 years ago)

Levofloxacin Ophthalmic Solution 0.5%

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations:

Cause type: cGMP deviation

Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.

What was recalled

Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10

Affected NDC 17478-0106-10

Compare with the code on your package — it is the most precise check available.

Drug: Levofloxacin Category: Eye Drops & Ophthalmic

Recalling firm
Akorn, Inc.
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0142-2023 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other Levofloxacin recalls

See all
Class III · Low risk

Levofloxacin Tablets

Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.

Terminated Labeling / mix-up Macleods Pharma USA, INC NDC 33342-022-08 D-0162-2023
Class II · Moderate risk

Levofloxacin Tablets

cGMP deviations: Temperature abuse

Terminated Temperature excursion Mckesson Medical-Surgical Inc. Corporate Office NDC 0904-6352-61 D-1088-2022

Other recalls by Akorn, Inc.

All 2022 recalls