Winder Laboratories, LLC Morphine Sulfate Oral Solution 100 mg / 5 mL , 30 mL recall: Correct Labeled Product Mispack-Size stated on carton label did not match
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
The hazard: Drug safety concern
The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.
What the notice says: Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.
Recall details
- Recall number
- D-0223-2026
- Published
- December 17, 2025
- Risk level
- Class III
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Winder Laboratories, LLC
- Product type
- Prescription & OTC drugs
- Units affected
- 3,528 30 mL Bottles
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Lot 1312405; Exp 09/28/2027
Products covered by 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
Check your product
The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- 1312405
Best-by / use-by date
Printed beside the lot code, not on the price sticker.
- 09
- 28
- 2027 — 3
- 528 30 mL Bottles
NDC number
On the carton and again on the bottle or blister label.
- 75826-131-01
Package size
Match the net weight or the piece count on the front of the pack.
- 100 mg
- 5 mL
- 20 mg
- 30 mL
Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Drug safety
Winder Laboratories, LLC — The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.
- Check the lot number on your pack against the codes listed above.
- Ask the dispensing pharmacy for a replacement from an unaffected lot.
- Keep the carton; the lot number is often printed only on the outer pack.
- Report side effects you think the product caused to FDA MedWatch.
What the company owes you
A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.
- The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
- Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
- Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
- Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.
Company contact: Winder Laboratories, LLC — 716 Patrick Industrial Ln, Winder, GA, 30680-8333
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Winder Laboratories, LLC prescription & otc drugs recalled?
Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton. Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: lot code 1312405; best-by date 09 or 28. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Check the lot number on your pack against the codes listed above.
Can I get my money back?
The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
Where was the recalled product sold?
It was distributed nationwide.
Related recalls
-
Class III · 7 months ago
Winder Laboratories, LLC Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx recall: Subpotent. During an FDA inspection it was discovered that the product
Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.
-
Class II · 11 days ago
K.C. Pharmaceuticals, Inc. Sterile Lubricant Dry Eye Relief Eye Drops, 0.5 FL OZ recall: Lack of Assurance of Sterility
Lack of Assurance of Sterility
-
Class II · 11 days ago
Carolina Infusion, LLC Quad-Mix Injectable, Packaged in single-use dosage syringes recall: Lack of Assurance of Sterility: Related to processing equipment used
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
-
Class II · 11 days ago
Carolina Infusion, LLC Tirzepatide/Cyanocobalamin 26/2 MG/ML Injectable recall: Lack of Assurance of Sterility: Related to formulation using bacteriostic
Lack of Assurance of Sterility: Related to formulation using bacteriostic water; Related to processing equipment used in compounded product.
-
Class II · 11 days ago
Carolina Infusion, LLC Tri-MIX ,30/1/20, injectable recall: Lack of Assurance of Sterility: Related to processing equipment used
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.
-
Class II · 11 days ago
Carolina Infusion, LLC Tri-MIX ,30/1/10, injectable recall: Lack of Assurance of Sterility: Related to processing equipment used
Lack of Assurance of Sterility: Related to processing equipment used in compounded product.