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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- MORPHINE SULFATE, Winder Laboratories LLC
- Product type
- Morphine Sulfate Oral Solution
- Model numbers
- Lot 1312405, Exp 09/28/2027
- UPC codes
- 75826-129, 75826-130, 75826-131, 75826-129-05, 75826-129-17, 75826-130-05, 75826-130-17, 75826-131-15 +2 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 26, 2025
Reported by FDA DRUG
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
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
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
- Check the lot number on your Morphine Sulfate Oral Solution bottle against Lot 1312405.
- Verify the expiration date on the bottle is Exp 09/28/2027.
- 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.
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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.
Key Facts
- Recall date: November 26, 2025
- Quantity recalled: 3,528 bottles
- Mislabeling poses a high hazard level
- No reported injuries or incidents
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Safety Guide
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