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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95430

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 25, 2024
Product types
Drug
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Denison Pharmaceuticals, 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

2 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 2

Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155

D-0033-2025
Recall number
D-0033-2025
Initiated
September 25, 2024
Classification
Class III
Status
Ongoing
Quantity
72,648 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

Code information

Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024

Distribution pattern

Product was distributed to two accounts that may have distributed the product further to the Retail Level.

drug · product 2 of 2

Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018

D-0034-2025
Recall number
D-0034-2025
Initiated
September 25, 2024
Classification
Class III
Status
Ongoing
Quantity
105,048 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

Code information

Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025

Distribution pattern

Product was distributed to two accounts that may have distributed the product further to the Retail Level.