Winder Laboratories, LLC: Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 m

Winder Laboratories, LLC: Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, W

DrugsSource: FDA (drug) · Date: 2025-12-17

The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand: Winder Laboratories, LLC
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 / hazard: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Classification: Class III
Status: Ongoing
Distribution / sold at: U.S. Nationwide
Recall initiated: 2025-11-26
Code info: Lot 1312405; Exp 09/28/2027
Product quantity: 3,528 30 mL Bottles
Voluntary mandated: Voluntary: Firm initiated
City: Winder
State: GA
Country: United States
Event id: 98077