Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL
Recalled by Winder Laboratories, LLC
Class III — least serious
Using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
Winder Laboratories, LLC has recalled Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on December 17, 2025 and was initiated on November 26, 2025. It is classified as a Class III recall, which means using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.
What was recalled?
This recall covers Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, with approximately 3,528 30 mL Bottles affected. The company behind the recall is Winder Laboratories, LLC, based in Winder, GA. The FDA describes the product as: “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”
Why was Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL recalled?
According to the FDA, the stated reason for the recall is: “Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.”
What should you do?
If you think you may have bought Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, compare it against the product description and identifying codes (Lot 1312405; Exp 09/28/2027) before using it. This recall is currently listed as ongoing.
The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Winder Laboratories, LLC or your local health authority.
About this recall
This recall was distributed in GA. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.
Full recall details
- Status
- Ongoing
- Date reported
- December 17, 2025
- Recall started
- November 26, 2025
- Distributed in
- GA
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL recalled?+
According to the FDA: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle…
How serious is this recall?+
Class III — least serious. Using this product is not likely to cause health problems, but it breaks an FDA rule (for example, a labeling or packaging issue).
What should I do if I have Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0223-2026. Information last synced from the FDA on July 6, 2026.