Divalproex Sodium 250 mg tablets recalled for failed dissolution specifications
Amneal Pharmaceuticals is recalling Divalproex Sodium Extended-release Tablets 250 mg nationwide due to failed dissolution specifications. The tablets may not dissolve properly, affecting medication effectiveness.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall of a prescription drug with manufacturing defects affecting medication dissolution and efficacy. No illnesses have been reported, but this constitutes a risk-of-harm product without yet-reported injury, meeting High severity criteria.
Plain-English summary
Amneal Pharmaceuticals is recalling Divalproex Sodium Extended-release Tablets, USP 250 mg manufactured by Amneal Pharmaceuticals Pvt. Ltd. in Ahmedabad, India and distributed by Amneal Pharmaceuticals LLC in Bridgewater, New Jersey. This recall affects approximately 21,452 bottles of 100 tablets each and has nationwide distribution.
The tablets are being recalled because they failed dissolution specifications—a quality measure of how well tablets break down in the body. Failed dissolution can affect the medication's absorption and effectiveness.
The specific lot numbers involved are AR210704, AR210706, AR210707, AR210708, and AR210709, all with an expiration date of April 2024. Patients currently taking this medication should contact their healthcare provider immediately to discuss their treatment options. Do not stop taking this medication without medical guidance.
The recalled product
- Product
- DIVALPROEX SODIUM (DIVALPROEX SODIUM)
- Brand
- DIVALPROEX SODIUM
- Manufacturer
- Amneal Pharmaceuticals of New York, LLC
- Category
- Drug
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 (6)
- Lot # AR210704
- exp. date 04/2024 AR210706
- exp. date 04/2024 AR210707
- exp. date 04/2024 AR210708
- exp. date 04/2024 AR210709
- exp. date 04/2024
UPCs (2)
- 0365162755107
- 0365162757101
Distribution
Distributed nationwide across the United States.
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