Recall archive / FDA drug enforcement

Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /wind... — FDA record D-0223-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Nov 26, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Classification: Class III
Recalling firm: Winder Laboratories, LLC
Quantity: 3,528 30 mL Bottles
Agency-reported status: Ongoing
Source record identifier: D-0223-2026

Open the official record

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Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot 1312405; Exp 09/28/2027

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

U.S. Nationwide

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Dec 17, 2025
Recall initiation date: Nov 26, 2025
Center classification date: Dec 9, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.