Moxifloxacin Ophthalmic Solution (Lupin) – Impurity Specifications (2019)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-422-01.
Brand
Lupin Pharmaceuticals Inc.
Lot Codes / Batch Numbers
Lots: H701618, H701619, H701620, Exp March 2019, H702220, H702221, H702222, H702223, H702224, H702225, H702351, Exp April 2019, H702971, H702972, H702973, H702974, H703151, H703152, H703153, Exp June 2019, H703155, H703682, H703683, Exp July 2019, H704243, H704245, H704247, Exp September 2019, H704707, H704709, H705038, H705039, Exp October 2019, H705561, Exp November 2019, H800394, H800395, H800617, H800618, Exp January 2020, H801585, H801586, H801721, H801722, Exp March 2020, H802138, H802139, H802140, Exp April 2020, H802421, H802707, H802718, Exp May 2020, H803187, H803188, H803232, Exp June 2020, H803749, H803750, Exp July 2020, H804326, H804327, H804328, H804330, H804549, H804552, H804630, H804632, Exp September 2020, H805163, H805361, H805362, H805676, Exp November 2020, H805690, H805692, H805694, Exp December 2020
Products Sold
Lots: H701618, H701619, H701620, Exp March 2019; H702220, H702221, H702222, H702223, H702224, H702225, H702351, Exp April 2019; H702971, H702972, H702973, H702974, H703151, H703152, H703153, Exp June 2019; H703155, H703682, H703683, Exp July 2019; H704243, H704245, H704247, Exp September 2019; H704707, H704709, H705038, H705039, Exp October 2019; H705561, Exp November 2019; H800394, H800395, H800617, H800618, Exp January 2020; H801585, H801586, H801721, H801722, Exp March 2020; H802138, H802139, H802140, Exp April 2020; H802421, H802707, H802718, Exp May 2020; H803187, H803188, H803232, Exp June 2020; H803749, H803750, Exp July 2020; H804326, H804327, H804328, H804330, H804549, H804552, H804630, H804632, Exp September 2020; H805163, H805361, H805362, H805676, Exp November 2020; H805690, H805692, H805694, Exp December 2020
Lupin Pharmaceuticals Inc. is recalling Moxifloxacin Ophthalmic Solution USP, 0.5%, 3 mL bottle, Rx only, Manufactured by: Lupin Limited, Pi due to Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026