FlaggedRx← Medication recall checkHome
Class III · Lower riskActive recall

Morphine Sulfate

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot 1312405; Exp 09/28/2027
Where it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made by/winder Laboratories, LLC, Winder, GA 30680
Brand nameMORPHINE SULFATE
Generic nameMORPHINE SULFATE
Active ingredient(s)MORPHINE SULFATE
Distributed by / forWinder Laboratories, LLC
NDC75826-131-01
Show the full FDA record
Full product labelMorphine 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 firmWinder Laboratories, LLC
DistributionU.S. Nationwide
Quantity3,528 30 mL Bottles
Recall initiated2025-11-26
Report date2025-12-17
Recall completed
Recall numberD-0223-2026
ClassificationClass III
FDA statusOngoing
Origin on fileWinder GA United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.