Divalproex Sodium Delayed-Release Tablets Recalled Due to Presence of Foreign Tablets
Bionpharma Inc. is recalling Divalproex Sodium Delayed-Release Tablets, 500 mg, because some bottles may contain foreign tablets or capsules.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The FDA has classified this as a Class II recall, which involves a situation where the probability of adverse health consequences is remote.
Plain-English summary
Bionpharma Inc. is recalling Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, in 500-tablet bottles (Lot# 704C003, Exp. 12/31/2028) due to the presence of foreign tablets or capsules in some bottles.
This recall affects Divalproex Sodium Delayed-Release Tablets, 500 mg, distributed nationwide in the United States. The affected product is identified by NDC 69452-435-30.
Consumers should contact their pharmacist or the manufacturer to discuss the return or replacement of the affected medication.
The recalled product
- Product
- DIVALPROEX SODIUM (DIVALPROEX SODIUM)
- Brand
- DIVALPROEX SODIUM
- Manufacturer
- Bionpharma Inc.
- Category
- Drug — Prescription Medication
- Hazard
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# 704C003
- Exp. 12/31/2028
Distribution
Distributed nationwide across the United States.
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