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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94727

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

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Event summary

Timeline bucket
May 28, 2024
Product types
Drug
Classifications
Class II
Statuses
Completed
Recalling firm wording
Winder Laboratories, LLC

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

Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,

D-0545-2024
Recall number
D-0545-2024
Initiated
May 28, 2024
Classification
Class II
Status
Completed
Recalling firm
Winder Laboratories, LLC
Quantity
473 cases (5676 Bottles)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

Code information

Lot#: 1142404 Exp. Date 02/27/2027

Distribution pattern

Nationwide within the United States