November 2025 FDA Recall Morphine Sulfate by Winder Laboratories, Llc
D-0223-2026 - Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
This Class III drug recall was voluntarily initiated by Winder Laboratories, Llc on November 26, 2025 for the product Morphine Sulfate. The FDA reported the reason for recall as correct labeled product mispack-size stated on carton label did not match the size of the bottle in the carton.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0223-2026
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
11-26-2025
12-17-2025
3,528 30 mL Bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Winder Laboratories, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# Lot 1312405; Exp 09/28/2027
