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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89268

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 22, 2021
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Lupin Pharmaceuticals Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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.

D-0326-2022
Recall number
D-0326-2022
Initiated
December 22, 2021
Classification
Class III
Status
Terminated
Quantity
50,832 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

Lot #: H003037, exp. date May 2022; H100132, exp. date June 2022; H100847, exp. date October 2022

Distribution pattern

Nationwide in the USA and Puerto Rico