Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder
Summary
The FDA issued a Class III for Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For by Winder Laboratories, LLC. Reason: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton..
Details
Source
Drug Recall
External ID
D-0223-2026
Action Date
2025-12-17
Status
Ongoing
Category
drug
Product Description
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC, Winder, GA 30680. NDC: 75826-131-01
Lot/Code Info: Lot 1312405; Exp 09/28/2027
Quantity Affected: 3,528 30 mL Bottles
Reason for Recall
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Distribution
U.S. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-11-26
Company
Winder, GA
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 54 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Winder Laboratories, LLC has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Winder Laboratories, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Winder Laboratories, LLC have FDA actions?
Winder Laboratories, LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0223-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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