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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Morphine Sulfate Oral Solution Recalled Due to Packaging Size Error

Agency Publication Date: December 9, 2025
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Summary

Winder Laboratories, LLC is recalling 3,528 bottles of Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg / mL). The recall was initiated because the product was mispacked; the size stated on the outer carton label does not match the actual size of the bottle inside the carton. Consumers who use this medication should be aware that the labeling discrepancy could lead to confusion regarding the amount of medication available in the container.

Risk

The size stated on the outer carton label is incorrect and does not match the physical bottle size inside, which could potentially lead to dosage or supply miscalculations. No injuries or adverse events have been reported to date.

What You Should Do

  1. Check your medication packaging for Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg / mL) in 30 mL bottles with NDC 75826-131-01.
  2. Specifically look for Lot number 1312405 with an expiration date of 09/28/2027.
  3. If you have health concerns or questions about your dose, contact your healthcare provider or pharmacist.
  4. Return any unused product to the place of purchase for a refund, throw it away, or contact Winder Laboratories, LLC for further instructions.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 if you have additional questions or wish to report an issue.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Morphine Sulfate Oral Solution (30 mL)
Variants: 100 mg / 5 mL (20 mg/mL), Rx Only, For Oral Use Only
Lot Numbers:
1312405 (Exp 09/28/2027)
NDC:
75826-131-01

Size stated on carton label did not match the size of the bottle in the carton.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98077
Status: Active
Manufacturer: Winder Laboratories, LLC
Sold By: pharmacies
Manufactured In: United States
Units Affected: 3,528 30 mL Bottles
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.