Divalproex Sodium Extended-Release Tablets Recalled for Failed Dissolution Specifications
Amneal Pharmaceuticals is recalling 4,309 bottles of Divalproex Sodium Extended-Release Tablets (250 mg) due to failed dissolution specifications. The tablets may not dissolve properly, potentially affecting medication effectiveness.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II drug recall with no reported illnesses or injuries. However, failed dissolution specifications on an essential medication represent a risk of harm—the medication may not release properly, potentially causing therapeutic failure. This fits the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Amneal Pharmaceuticals of New York, LLC issued a recall of Divalproex Sodium Extended-Release Tablets, USP, 250 mg. The recall affects 4,309 bottles from Lot #AR210705, which expires in April 2024. The product was distributed nationwide in the United States and can be identified by package NDC 65162-755-10 and related NDCs.
The recall was initiated due to failed dissolution specifications, meaning the tablets do not meet standards for how they dissolve and release the active medication in the body.
Patients and healthcare providers who may have this medication should check the lot number on the bottle to verify whether they possess the recalled product.
The recalled product
- Product
- DIVALPROEX SODIUM (DIVALPROEX SODIUM)
- Brand
- DIVALPROEX SODIUM
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Category
- Drug
- Hazard
- failed-dissolution
- medication-efficacy
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 #: AR210705
- Exp 04/2024
UPCs (2)
- 0365162755107
- 0365162757101
Distribution
Distributed nationwide across the United States.
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- HighDivalproex Sodium 250 mg tablets recalled for failed dissolution specifications
FDA (Drugs) · 2024-04-03
- HighFDA Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2022-08-03
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