Morphine sulfate oral solution recalled due to carton label size mismatch
Winder Laboratories is recalling 3,528 bottles of morphine sulfate oral solution because the carton label states an incorrect bottle size that does not match the actual bottle inside.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is a documentation and packaging-only issue with no reported illnesses or injuries. The FDA classified this as a Class III recall. The hazard is a mismatch between carton label information and the actual bottle size, fitting the criterion for documentation issues and packaging-only problems.
Plain-English summary
Winder Laboratories, LLC is recalling 3,528 bottles of Morphine Sulfate Oral Solution 100 mg/5 mL (20 mg/mL) due to a labeling and packaging discrepancy.
The carton label states an incorrect bottle size that does not match the actual size of the bottle contained inside. The company identified this discrepancy and is conducting a voluntary recall.
The affected product is Lot 1312405 with an expiration date of 09/28/2027 and was distributed nationwide in the United States. The product is manufactured by Winder Laboratories, LLC in Winder, Georgia.
Consumers with this product should verify the actual bottle size against the carton labeling. If a discrepancy is identified, consumers should contact their pharmacy or healthcare provider.
The recalled product
- Product
- MORPHINE SULFATE (MORPHINE SULFATE)
- Brand
- MORPHINE SULFATE
- Manufacturer
- Winder Laboratories, LLC
- Category
- Drug — Oral Solution
- Hazard
- mis-labeling
- packaging-error
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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