Winder Laboratories LLC
NDC labeler code: 75826
What is a labeler?
The company whose name is on the package and in the FDA’s National Drug Code (NDC) Directory. It may make the medicine itself or sell medicine made by another company. The first part of every NDC code identifies the labeler.
Official FDA data only
Products, approvals and recalls come from the FDA (NDC Directory, Drugs@FDA, enforcement reports). Recalls are linked to this company by the NDC labeler code on the recalled product.
Questions about your medicine: ask your doctor or pharmacist. In an emergency, call 911.
Prescription medicines
- DextroamphetamineZenzedi, Xelstrym, Dexedrine Spansule · 7 products
- Morphine sulfateMs Contin, Mitigo, Duramorph · 3 products
- Diphenoxylate hydrochloride and atropine sulfateLomotil · 1 product
- Chlordiazepoxide hydrochloride and clidinium bromideLibrax · 1 product
FDA applications for these products
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Approved | Application | Medicine | Sponsor |
|---|---|---|---|
| July 8, 2024 | ANDA212344 | Chlordiazepoxide hydrochloride and clidinium bromide CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE | Winder Labs LLC |
| June 7, 2021 | ANDA212160 | Dextroamphetamine DEXTROAMPHETAMINE SULFATE | Winder Labs LLC |
| February 12, 2021 | ANDA211454 | Morphine sulfate MORPHINE SULFATE | Winder Labs LLC |
| January 27, 2021 | ANDA211362 | Diphenoxylate hydrochloride and atropine sulfate DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | Winder Labs LLC |
The sponsor is the company that holds the FDA application; it can differ from the labeler.
Recall timeline
2025
-
November 26, 2025 · Class III · Ongoing · D-0223-2026 · Morphine sulfate
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
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
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Next steps
- Find a pharmacy near youAsk which company made your medicine and whether it is recalled
- Latest FDA drug recallsAll companies, newest first
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- All prescription drugs A to ZSearch by generic, brand or Spanish name
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026