Morphine Sulfate Oral Solution 100 mg / 5 mL recall (Winder Laboratories, LLC)
DrugClass IIIOngoing
Summary: Winder Laboratories, LLC is recalling 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.
What is being recalled
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
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
U.S. Nationwide
How to tell if yours is affected
Lot 1312405; Exp 09/28/2027
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0223-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | November 26, 2025 |
| Reported | December 17, 2025 |
| Company | Winder Laboratories, LLC |
| Company location | Winder, GA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 3,528 30 mL Bottles |
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