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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98077

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

Open FDA event record

Event summary

Timeline bucket
November 26, 2025
Product types
Drug
Classifications
Class III
Statuses
Ongoing
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

Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01

D-0223-2026
Recall number
D-0223-2026
Initiated
November 26, 2025
Classification
Class III
Status
Ongoing
Recalling firm
Winder Laboratories, LLC
Quantity
3,528 30 mL Bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

Code information

Lot 1312405; Exp 09/28/2027

Distribution pattern

U.S. Nationwide