← FDA ENFORCEMENT
D-0223-2026Class III

Winder Laboratories, LLC

Recalling firm
Winder Laboratories, LLC
Product type
Drug
Status
Ongoing
Report date
2025-12-17
Distribution
U.S. Nationwide
Firm state
GA
Product quantity
3,528 30 mL Bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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

Code / lot info

Lot 1312405; Exp 09/28/2027

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.