Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL) recall
FDA recall D-0223-2026 · initiated Nov 26, 2025
Winder Laboratories, LLC recalled Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL) in Nov 2025 — an FDA Class III recall (D-0223-2026) because Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 3,528 30 mL Bottles
Details
- 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
- Recalling company
- Winder Labs LLC
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- U.S. Nationwide
- Initiated
- Nov 26, 2025
- FDA report date
- Dec 17, 2025
Frequently asked
- Was Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL) recalled?
- Winder Laboratories, LLC recalled Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL) in Nov 2025 — an FDA Class III recall (D-0223-2026) because Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL) recalled?
- Per the FDA enforcement record, the reason for recall D-0223-2026 was: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
- Is a recalled Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL) are affected?
- Distributed: U.S. Nationwide. The recall covers these lots — Lot 1312405; Exp 09/28/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0223-2026.