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
morphine sulfate 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 recalled by FDA. Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
By RecallRadar Editorial Team
Sourced from FDA. Last reviewed March 4, 2026.
This recall involves safety concerns. Take action promptly.
✨ Plain-English Summary
morphine sulfate 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 recalled by FDA. Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Is This Recall Still Active?
Status: Yes - Active
This recall is currently active. If your device matches the affected models, follow the official instructions as soon as possible.
Source & Verification
This page summarizes the official notice and keeps key facts easy to verify.
- Official source
- FDA
- Announced by source
- November 26, 2025
- Last reviewed by RecallRadar
- March 4, 2026
What You Should Do
- 1## 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
- 2NDC: 75826-131-01 Agency: FDA | Category: drug Reason: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton. What to do:
- 3Stop using the product if your lot/model matches.
- 4Check the FDA notice for specifics.
What's Being Recalled
Quoted source excerpt from the official notice.
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Who's Affected
Specific models and identifiers listed in the source notice:
Model #1
Lot 1312405; Exp 09/28/2027
| # | Model |
|---|---|
| 1 | Lot 1312405; Exp 09/28/2027 |
Technical model codes are manufacturer identifiers. Match both the product name and model code from your device settings, label, or packaging.
Frequently Asked Questions
Is my morphine sulfate device affected?
Check the affected models section on this page. The official notice currently lists Lot 1312405; Exp 09/28/2027.
What is the remedy for this recall?
## 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 Agency: FDA | Category: drug Reason: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton. What to do: 1. Stop using the product if your lot/model matches. 2. Check the FDA notice for specifics. 3. Follow remedy instructions.
Where can I verify recall details?
Use the official source link in this page to confirm dates, eligibility, and next steps: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts
Keep browsing with these internal hubs: morphine sulfate recall hub and Food & Drug recall hub.
Official Resources
Use these primary sources for final eligibility and claim instructions.
View official notice from FDASee an inaccuracy?
Help us improve the accuracy of this recall information.
Quick Info
- Brand
- morphine sulfate
- Category
- drug
- Source Agency
- FDA
- Announced
- November 26, 2025
- Country
- US
- Status
- Active
Source & Verification
Sourced from FDA. Last reviewed March 4, 2026.
- Official source
- FDA
- Announced by source
- November 26, 2025
- Last reviewed by RecallRadar
- March 4, 2026
Official Resources
Use these primary sources for final eligibility and claim instructions.
Open Official Recall NoticeView official notice from FDAStay Protected
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