FDA Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications
Sun Pharmaceutical recalls Divalproex Sodium delayed-release tablets due to failed dissolution specifications discovered during stability testing. The tablets may not dissolve as intended.
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 with no reported hospitalizations or injuries. The hazard involves failed dissolution of tablets used for seizure control, which is a risk-of-harm product, but no actual injuries have been documented. Per the severity rubric, theoretical hazards without reported harm are scored at most 3 (High).
Plain-English summary
Divalproex Sodium is a prescription medication used to treat seizures and certain mood disorders. Sun Pharmaceutical Industries Inc is recalling 9,552 bottles of Divalproex Sodium delayed-release tablets, 500mg strength (Lot HAC1312A, expiration May 2024), which were distributed nationwide in the USA.
The recall was initiated because the tablets failed dissolution specifications during routine stability testing. Dissolution tests verify that tablets break down properly in the stomach to allow proper absorption of the medication.
Consumers who have obtained this medication should contact their healthcare provider for guidance. Because this is a prescription medication, healthcare providers and pharmacies can provide appropriate follow-up, including options for replacement medication.
The recalled product
- Product
- DIVALPROEX SODIUM (DIVALPROEX SODIUM)
- Brand
- DIVALPROEX SODIUM
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug
- Hazard
- Affected units
- 9,552
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: HAC1312A
- EXP. 05/2024
UPCs (2)
- 0362756796836
- 0362756798830
Distribution
Distributed nationwide across the United States.
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Similar recalls
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