FDA recall D-0223-2026

Winder Laboratories, LLC · Class III · drug

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

Reason for recall

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

Distribution

U.S. Nationwide

Key facts

Status: Ongoing
Initiation date: 2025-11-26
Report date: 2025-12-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: Winder, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0223-2026