Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported January 12, 2022
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.
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Lupin Pharmaceuticals Inc. recalled Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Li… - a low-severity action.
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Li… was recalled by Lupin Pharmaceuticals Inc. in January 12, 2022. Reason: Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect…. Check the official notice for the remedy. Verify recall #D-0326-2022 with the FDA Drug before acting.
The recall
Lupin Pharmaceuticals Inc. issued this low-severity FDA Drug recall-Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect….
- Low
- severity level
- Class III
- classification
- January 12, 2022
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0326-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0326-2022) was formally reported on January 12, 2022, with the manufacturer initiating the action on December 22, 2021. It is classified under Low severity (Class III), with a current status of Terminated. Lupin Pharmaceuticals Inc. is listed as the recalling firm, operating out of Baltimore, MD. Federal records list the affected scope as 50,832 bottles.
The documented reason for this recall is: Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration. Distribution data in the federal record shows the product reached: Nationwide in the USA and Puerto Rico. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug and 1 from Lupin Pharmaceuticals Inc. - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
50,832 bottles
Related Recalls
6
5 from same agency
Product description
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.
Reason for recall
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0326-2022 |
| Date reported | January 12, 2022 |
| Date initiated | December 22, 2021 |
| Recalling firm | Lupin Pharmaceuticals Inc. |
| Firm location | Baltimore, MD |
| Affected scope | 50,832 bottles |
| Distribution | Nationwide in the USA and Puerto Rico |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0326-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 50,832 bottles.
Why was this product recalled? ▼
Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 12, 2022. Severity: Low. Recall number: D-0326-2022.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the USA and Puerto Rico.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0326-2022) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Safecor Health, LLC · 2026-05-27
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fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
IntegraDose Compounding Services LLC · 2026-05-27
FDA Drug Moderate
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, …
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported January 12, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.