Lower riskDrug recall · FDA · Published October 20, 2021
Lupin Gatifloxacin Eye Drops Recall: Stability Issues May Affect Drug Concentration
Lupin Pharmaceuticals recalls Gatifloxacin Ophthalmic Solution 0.5% 2.5mL bottles due to stability issues that could alter drug concentration. Rx only product manufactured in India with specific lot and expiration.
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Take action
Contact the company
📍Recalling firmLupin Pharmaceuticals Inc.Harborplace Tower, 111 S Calvert St Fl 21st · Baltimore, MD 21202-6174
“Lupin Gatifloxacin Eye Drops Recall: Stability Issues May Affect Drug Concentration.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35640-lupin-gatifloxacin-eye-drops-recall-stability-issues-may-affect-drug. Based on FDA recall #D-0091-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0091-2022%22&limit=1).
The FDA announced on 2021-10-20 that Lupin Pharmaceuticals Inc. is recalling Gatifloxacin Ophthalmic Solution, 0.5%, due to failed stability specifications. The agency classified the Class III recall as voluntary and terminated.
How to tell if you have it
Brand: Lupin Pharmaceuticals
Product: Gatifloxacin Ophthalmic Solution, 0.5%
Size: 2.5 mL bottle
NDC: 68180-435-01
Lot #: H002512
Expiration date: March 2022
Manufacturer: Lupin Limited, Pithampur (M.P.) 454 775, INDIA
The hazard
According to the FDA, out-of-specification results in a water loss test might affect the assay content and alter drug concentration.
Context
GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since 2013-01-31. Other recent recalls of similar products include Lupin Clobetasol Cream Recall (2026-08-03), Lupin Glucagon Emergency Kit Recall (2026-06-23), and Lupin prednisolone acetate ophthalmic suspension recall (2026-06-04). Other recent recalls of similar products include Cipla Phytonadione Injectable Emulsion Recall (2025-10-31), Sun Pharmaceutical Fluocinolone Acetonide Solution Recall (2025-12-30), and SUN PHARMACEUTICAL Clindamycin Phosphate Topical Solution Recall (2025-11-26).
How to tell if you have this one
Check for the 2.5 mL bottle labeled 'Gatifloxacin Ophthalmic Solution 0.5%' with lot number H002512 and expiration date March 2022. This prescription-only eye drop was manufactured in India by Lupin Limited.
Brand
Lupin Pharmaceuticals
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the lot number and expiration date on the bottle to confirm if it matches the recalled batch.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The recall is due to potential stability issues that might affect drug concentration, but the product is not unsafe in normal use. It may not be as effective as intended.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0091-2022 (October 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0091-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.