HIGH

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.

Quick Facts at a Glance

Recall Date
November 26, 2025
Hazard Level
HIGH
Brands
MORPHINE SULFATE, Winder Laboratories LLC
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Winder Laboratories, LLC or your healthcare provider for guidance. Notification method: N/A

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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.

Key Facts

  • Recall date: November 26, 2025
  • Quantity recalled: 3,528 bottles
  • NDC Code: 75826-131-01
  • Mislabeling poses a high hazard level
  • No reported injuries or incidents

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Lot 1312405
Exp 09/28/2027
UPC Codes
75826-129
75826-130
75826-131
+7 more
Affected States
ALL
Report Date
December 17, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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