FDAClass IIIDecember 17, 2025

Morphine Sulfate Oral Solution 100 mg / recall

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…

Why was Morphine Sulfate Oral Solution 100 mg / recalled?

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 1312405; Exp 09/28/2027

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…
Recalling firm
Winder Laboratories, LLC
Quantity
3,528 30 mL Bottles
Distribution
U.S. Nationwide
Recall date
December 17, 2025
Classification
Class III
Status
Ongoing
Agency
FDA (drug)
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