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.
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: 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
- dissolution-failure
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.
Related recalls
Same brand · DIVALPROEX SODIUM
- HighDivalproex Sodium 250 mg tablets recalled for failed dissolution specifications
FDA (Drugs) · 2024-04-03
- HighDivalproex Sodium Extended-Release Tablets Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-08-31
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27