FDA Drug recall D-0223-2026
Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC,…
- FDA Drug
- Class III
- ongoing
- Published 2025-12-17
On 2025-12-17 the FDA classified a Class III recall of Morphine Sulfate Oral Solution 100 mg / 5 mL (20 mg* / mL), 30 mL, Rx Only, For Oral Use Only, Manufactured By: /winder Laboratories, LLC,… by Winder Laboratories, citing correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0223-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-11-26 |
| Published | 2025-12-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Winder Laboratories |
| Distribution | US |
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
Reason
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Identifiers
| ndc | 75826-129-05 |
|---|---|
| ndc | 75826-129-17 |
| ndc | 75826-130-05 |
| ndc | 75826-130-17 |
| ndc | 75826-131-15 |
| ndc | 75826-131-04 |
| ndc | 75826-131-01 |
| code_info | Lot 1312405; Exp 09/28/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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FDA Food · Class III · 2026-03-25 · Winder Laboratories - Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane…
FDA Drug · Class II · 2024-06-19 · Winder Laboratories
All Winder Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0223-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.