Use cautionDrug recall · FDA · Published December 22, 2021
Lupin Recalls Gatifloxacin Eye Drops Due to Stability Issues
Lupin Pharmaceuticals recalls specific lots of Gatifloxacin Ophthalmic Solution due to failed stability specifications that may alter drug concentration.
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
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Contact the company
📍Recalling firmLupin Pharmaceuticals Inc.Harborplace Tower, 111 S Calvert St Fl 21st · Baltimore, MD 21202-6174
✎ GovInfoNow plain-language explainer
Lupin Pharmaceuticals Inc. is recalling Gatifloxacin Ophthalmic Solution, 0.5%, because it failed stability specifications in a water loss test. This defect might affect the assay content and alter the drug's concentration, potentially impacting its effectiveness. The recall covers 50,832 bottles distributed nationwide in the USA and Puerto Rico. Read more at govinfonow.com/recall/35417-lupin-recalls-gatifloxacin-eye-drops-due-to-stability-issues.
“Lupin Recalls Gatifloxacin Eye Drops Due to Stability Issues.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35417-lupin-recalls-gatifloxacin-eye-drops-due-to-stability-issues. Based on FDA recall #D-0326-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0326-2022%22&limit=1).
Lupin Pharmaceuticals Inc. recalled Gatifloxacin Ophthalmic Solution after the FDA announced the Class III recall on December 22, 2021. The product failed stability specifications, which might affect assay content and alter drug concentration.
How to tell if you have it
Brand: Lupin
Product: Gatifoxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle
NDC: 68180-435-01
Lot codes: H003037 (exp. May 2022), H100132 (exp. June 2022), H100847 (exp. October 2022)
Quantity: 50,832 bottles
Distribution: Nationwide in the USA and Puerto Rico
The hazard
The recall involves out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration. The FDA classified this as a Class III recall.
Context
GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since January 31, 2013. Other recent recalls of similar products include Lupin Clobetasol Cream (August 3, 2026), Lupin Glucagon Emergency Kit (June 23, 2026), and Lupin prednisolone acetate ophthalmic suspension (June 4, 2026). Other recent recalls of similar products include Sun Pharmaceutical Fluocinonide Cream (March 25, 2026), Blaine Labs TERPENICOL Antifungal Solution (April 8, 2026), and Sun Pharmaceutical Fluocinolone Acetonide Solution (December 30, 2025).
How to tell if you have this one
Check your bottle for NDC 68180-435-01 and one of the following lot numbers with their expiration dates: Lot H003037 (exp. May 2022), Lot H100132 (exp. June 2022), or Lot H100847 (exp. October 2022). The product is a 2.5 mL Rx-only bottle manufactured by Lupin Limited in India.
Brand
Lupin
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check your lot number
Verify if your Gatifloxacin Ophthalmic Solution bottle matches the recalled NDC and lot numbers listed in the record.
Contact your pharmacist or doctor
Since the remedy is not stated, consult your healthcare provider for guidance on how to proceed with this specific medication.
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 9 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 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-0326-2022 (December 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0326-2022 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 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.