Exact FDA event identifier

Event 93236

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

Event summary

Timeline bucket: October 20, 2023
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Edenbridge 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine, packaged in 118 mL (4 Fl oz) bottles, Rx only, Manufactured for: Edenbridge Pharmaceuticals, LLC Parsippany, NJ 07054, NDC 42799-217-01

D-0080-2024

Recall number: D-0080-2024
Initiated: October 20, 2023
Classification: Class III
Status: Terminated
Recalling firm: Edenbridge Pharmaceuticals, LLC
Quantity: 4548 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug

Code information

Lot#: 23ZCP1, Exp. Date 02/22/2026;Lot #:23ZDR1, Exp. Date 03/09/2026

Distribution pattern

Nationwide within the United States