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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About This Product

Morphine Sulfate Oral Solution is an opioid medication used for pain management. Patients typically use it under a healthcare provider's guidance for moderate to severe pain relief.

Why This Is Dangerous

The labeling error in the packaging can result in patients receiving incorrect dosages, leading to severe health risks associated with opioid misuse or overdose.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face health risks from incorrect dosing. The recall may also lead to inconvenience for those relying on this medication for pain management.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on your Morphine Sulfate Oral Solution bottle against Lot 1312405.
  2. Verify the expiration date on the bottle is Exp 09/28/2027.
  3. If the lot number matches, stop using the product immediately.

Where to find product info

The lot number and expiration date can be found on the label of the bottle or on the carton packaging.

What timeline to expect

Expect a refund or replacement processing time of approximately 4-6 weeks.

If the manufacturer is unresponsive

  • Document all correspondence with Winder Laboratories regarding your recall inquiry.
  • Try reaching out again after a week if you do not receive a response.

How to prevent similar issues

  • Always verify packaging and labeling before using medications.
  • Consult with your healthcare provider about any concerns with prescribed medications.

Documentation advice

Keep records of your purchase, including receipts, lot numbers, and any communication with the manufacturer.

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.

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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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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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