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

FDA recall notice · announced December 17, 2025 · Winder Laboratories

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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.

Notes

Distribution: U.S. Nationwide
Lot/code information: Lot 1312405; Exp 09/28/2027
Quantity: 3,528 30 mL Bottles
Status: Ongoing
Products in this recall event:
- 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 (D-0223-2026)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.