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Class III: unlikely to cause harmOngoing

Winder Laboratories Morphine Sulfate Oral Solution 100 mg / 5 mL Recall

Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Us…

Winder Laboratories, LLC · Winder, GA

Risk level
Class III
Reported by FDA
Dec 17, 2025
Recall ID
D-0223-2026
Check your lot numberHow we source this data

Summary

Winder Laboratories recalled Morphine Sulfate Oral Solution 100 mg / 5 mL starting Nov 26, 2025. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0223-2026 on Dec 17, 2025. Reason: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton. Status: Ongoing.

Why it was recalled

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

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

Lot numbers, UPCs & expiration codes

Lot 1312405; Exp 09/28/2027

Where it was sold

U.S. Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0223-2026
Classification
Class III
Status
Ongoing
Recall initiated
Nov 26, 2025
FDA report date
Dec 17, 2025
Quantity
3,528 30 mL Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Winder Laboratories, LLC

Original FDA data

Every field from FDA enforcement report D-0223-2026, exactly as published.

Show all FDA fields
City
Winder
State
GA
Status
Ongoing
Country
United States
Event ID
98077
Address
716 Patrick Industrial Ln
Code information
Lot 1312405; Exp 09/28/2027
Postal code
30680-8333
Report date
Dec 17, 2025
Product type
Drugs
Recall number
D-0223-2026
Classification
Class III
Recalling firm
Winder Laboratories, LLC
Product quantity
3,528 30 mL Bottles
Reason for recall
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
U.S. Nationwide
Recall initiation date
Nov 26, 2025
Center classification date
Dec 9, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0223-2026, published Dec 17, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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