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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94981

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

Open FDA event record

Event summary

Timeline bucket
July 18, 2024
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Granules Consumer Health 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

Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India

D-0627-2024
Recall number
D-0627-2024
Initiated
July 18, 2024
Classification
Class III
Status
Terminated
Quantity
21,192 Bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Label mix-up

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Label mix-up: Carton incorrectly labeled.

Code information

Lot #: 31670346AA, Exp 12/31/2026

Distribution pattern

Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.