Class IIIOngoing

Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL) recall

FDA recall D-0223-2026 · initiated Nov 26, 2025

Unlikely to cause harm but violates FDA labeling or manufacturing regulations.

Why it was recalled

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

Details

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
Recalling company: Winder Labs LLC
Classification: Class III
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: U.S. Nationwide
Initiated: Nov 26, 2025
FDA report date: Dec 17, 2025

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0223-2026 ↗

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