Morphine sulfate oral solution recalled over a carton size mismatch
Winder Laboratories is recalling 3,528 bottles of Morphine Sulfate Oral Solution because the size stated on the carton label did not match the size of the bottle inside.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: Scored 2 under the rule that FDA Class III actions fall at 1 or 2: the record cites a carton and bottle size mismatch with no stated clinical consequence.
Plain-English summary
Morphine Sulfate Oral Solution, 100 mg / 5 mL (20 mg per mL), 30 mL, for oral use only, manufactured by Winder Laboratories, LLC of Winder, Georgia, under NDC 75826-131-01, is being recalled.
The reason given in the enforcement record is a correct labeled product mispack: the size stated on the carton label did not match the size of the bottle in the carton.
The recall covers 3,528 30 mL bottles from lot 1312405, expiry 09/28/2027. Distribution was nationwide in the United States. The FDA has classified the action as Class III, its least serious category.
Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific carton is affected and arrange a replacement.
The recalled product
- Product
- MORPHINE SULFATE (MORPHINE SULFATE)
- Brand
- MORPHINE SULFATE
- Manufacturer
- Winder Laboratories, LLC
- Category
- Drug — Opioid oral solution
- Hazard
- mispack
- labeling-error
- class-iii
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 1312405
- Exp 09/28/2027
UPCs (3)
- 0375826130058
- 0375826131154
- 0375826129052
Distribution
Distributed nationwide across the United States.
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