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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89624

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

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Event summary

Timeline bucket
February 21, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Morton Grove 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

Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.

D-0713-2022
Recall number
D-0713-2022
Initiated
February 21, 2022
Classification
Class II
Status
Terminated
Quantity
Unavailable

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.

Code information

Lot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23

Distribution pattern

Nationwide USA and Puerto Rico