Class III · Lower riskRecall completed
Gatifloxacin Ophthalmic Solution
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: H003037, exp. date May 2022; H100132, exp. date June 2022; H100847, exp. date October 2022
Where it was soldNationwide in the USA and Puerto Rico
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byLupin Limited, Pithampur (M.P.) 454 775, INDIA foreign manufacturer
| Distributed by / for | Lupin Pharmaceuticals Inc. |
| NDC | 68180-435-01 |
Show the full FDA record
| Full product label | Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01. |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 50,832 bottles |
| Recall initiated | 2021-12-22 |
| Report date | 2022-01-12 |
| Recall completed | 2022-09-12 |
| Recall number | D-0326-2022 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Baltimore MD United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.