Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 68180-0422-01 recalled?

Moxifloxacin · 1 BOTTLE in 1 CARTON (68180-422-01) / 3 mL in 1 BOTTLE

Yes — this exact package was recalled

3 FDA recalls name the code 68180-0422-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Moxifloxacin
Strength
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATE 5 mg/mL
Form
Solution/ Drops · Ophthalmic
Labeler
Lupin Pharmaceuticals, Inc.
Type
Human Prescription Drug
Product code
68180-0422

Recalls naming this package

Class III · Low risk

Moxifloxacin Ophthalmic Solution USP

Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.

Terminated Impurity / degradation Lupin Pharmaceuticals Inc. NDC 68180-422-01 D-0517-2019
Class III · Low risk

Moxifloxacin Ophthalmic Solution USP

Failed Impurities/Degradation Specifications: Out of specification test results in related substance at three-month long term stability study was obtained.

Terminated Impurity / degradation Lupin Pharmaceuticals Inc. NDC 68180-422-01 D-0484-2019
Class III · Low risk

Moxifloxacin Ophthalmic Solution USP

Failed Impurities/Degradation Specifications: An out-of-specification result in the related substance test during three month long-term stability study.

Terminated Impurity / degradation Lupin Pharmaceuticals Inc. NDC 68180-422-01 D-1050-2018

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler