Winder Laboratories Recalls Morphine Sulfate Oral Solution Over Labeling Error
Winder Laboratories, LLC recalled 3,528 bottles of Morphine Sulfate Oral Solution on November 26, 2025. The labeling error misrepresented the product size, leading to potential dosing issues. Consumers should stop using the product immediately and consult their healthcare provider.
Product Details
The recalled product is Morphine Sulfate Oral Solution 100 mg / 5 mL, packaged in 30 mL bottles. It is classified as a prescription-only medication and carries the NDC code 75826-131-01. The product was distributed nationwide across the U.S.
The Hazard
The recall stems from a mispackaging issue where the size stated on the carton label did not match the actual size of the bottle. This discrepancy poses a high risk of incorrect dosing, which can lead to serious health complications.
Reported Incidents
There have been no reported injuries or incidents directly associated with this recall. However, the potential for dosing errors raises significant safety concerns.
What to Do
Consumers and healthcare providers should stop using the recalled Morphine Sulfate Oral Solution immediately. Contact Winder Laboratories, LLC or your healthcare provider for further guidance on the recall and potential alternatives.
Contact Information
For further inquiries, consumers can reach Winder Laboratories, LLC directly. Visit the FDA recall page for more information at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0223-2026.