FDA Drugs recall ·
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL… recall
- Recall number
- D-0223-2026
- Date
- (initiated November 26, 2025)
- Company / brand
- Winder Laboratories, LLC
716 Patrick Industrial Ln, Winder, GA, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 3,528 30 mL Bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot 1312405; Exp 09/28/2027
Distribution
U.S. Nationwide
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0223-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.