Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Ma...

FDA Recall #D-0223-2026 — Class III — November 26, 2025

Recall #D-0223-2026 Date: November 26, 2025 Classification: Class III Status: Ongoing

Product Description

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

Reason for Recall

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

Recalling Firm

Winder Laboratories, LLC — Winder, GA

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

3,528 30 mL Bottles

Distribution

U.S. Nationwide

Code Information

Lot 1312405; Exp 09/28/2027

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated