CLASS III ONGOING Drug recall · Reported 17 Dec 2025 · FDA Enforcement Report
Morphine Sulfate Oral Solution 100 mg / (20 mg* / mL) recalled
Winder Laboratories is recalling Morphine Sulfate Oral Solution 100 mg / (20 mg* / mL), distributed nationwide in the US. The recall was initiated on 26 Nov 2025 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0223-2026
- FDA event ID
- 98077
- Recalling firm
- Winder Laboratories, Winder, GA
- Brand
- Morphine Sulfate
- Manufacturer
- Winder Laboratories LLC
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 26 Nov 2025
- FDA classified
- 9 Dec 2025
- Reported
- 17 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 26 Nov 2025 | Recall initiated by company | |
| 9 Dec 2025 | Classified by FDA | +13 days |
| 17 Dec 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Which lots are affected?
Lot 1312405; Exp 09/28/2027
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Winder Laboratories
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | CLASS III | Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx recalledMultivitamin | Winder Laboratories | Potency & Assay | 25 states |
| Drug | CLASS II | Phenazopyridine HCl Tablets USP, 100 mg recalled by Winder LaboratoriesPhenazopyridine Hydrochloride | Winder Laboratories | Other | Nationwide |
Other Morphine recalls
All 147| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets 30 mg recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200 | Hikma Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS III | Opium Tincture, USP (Deodorized), 10 mg/mL of anhydrous morphine recalledOpium Tincture Deodorized | Edenbridge Pharmaceuticals | Potency & Assay | Nationwide |