Winder Laboratories recalls Morphine Sulfate Oral Solution 100 mg/5 mL because carton size label does not match bottle
The size printed on the carton label of this 30 mL morphine oral solution does not match the size of the bottle inside, so the carton holds a different bottle than the label says.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall 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
- Company
- Winder Laboratories, LLC
- Hazard
- Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
- Units
- 3,528 30 mL Bottles
- Where sold
- U.S. Nationwide
- FDA classification
- Class III · Ongoing
- Classified by FDA
- December 9, 2025
- Recall started
- November 26, 2025
- FDA enforcement report
- December 17, 2025
- Identifiers
- Codes: Lot 1312405; Exp 09/28/2027
- FDA recall number: D-0223-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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.
- Classification
- Class III (Ongoing)
- Distribution
- U.S. Nationwide
- Quantity
- 3,528 30 mL Bottles
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