Information
Winder Laboratories Recalls Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL)
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0223-2026Drug / Pharmaceutical
Winder Laboratories Recalls Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL)
Winder Laboratories, LLC · Class III — Regulatory
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.
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
U.S. Nationwide
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA has classified this as a Class III recall — the lowest severity level — for a pharmaceutical product recalled by Winder Laboratories, LLC on November 26, 2025. Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton. This recall covers 3,528 30 mL Bottles, distributed in U.S. Nationwide. Class III recalls typically involve products unlikely to cause health problems but that violate FDA manufacturing or labeling regulations.
Sources: FDA openFDA Enforcement Database
This recall appears in: Other Injury Hazards.