Skip to content
Back to recalls
Drug FDA Class III Ongoing Mislabeling

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

Winder Laboratories, LLC Published Dec 17, 2025

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 40/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Winder Laboratories, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Affected products (1)

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

MORPHINE SULFATE · 3,528 30 mL Bottles

NDC: 75826-129, 75826-130, 75826-131, 75826-129-05, 75826-129-17, 75826-130-05, 75826-130-17, 75826-131-15, 75826-131-04, 75826-131-01
Lot codes: 1312405
Code info: Lot 1312405; Exp 09/28/2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Nov 26, 2025
  2. Published
    Dec 17, 2025
Recall number
D-0223-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.