Zydus Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications
Zydus Pharmaceuticals is recalling Divalproex Sodium Delayed Release Tablets because they failed dissolution specifications and long-term stability testing.
What this means for you
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 recall is classified as FDA Class II due to failed dissolution and stability specifications, which is a quality defect that may affect drug efficacy but does not involve reported injuries or high-risk pathogens.
Plain-English summary
Zydus Pharmaceuticals USA Inc is recalling Divalproex Sodium Delayed Release Tablets, USP, 500 mg. The affected products are available in 100-count and 500-count bottles and are prescription-only. The tablets were manufactured by Cadila Healthcare Ltd in Ahmedabad, India, and distributed by Zydus Pharmaceuticals in Pennington, New Jersey.
The recall was initiated because the product failed dissolution specifications and 9-month long-term stability testing. A total of 32,628 bottles were distributed nationwide. Specific lot numbers and expiration dates are listed in the recall documentation.
Consumers with these products should contact their healthcare provider or pharmacist for guidance on alternative treatments. The FDA classifies this as a Class II recall, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) 100 count (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Anticonvulsant
- Affected units
- 32,628
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 (20)
- a) MR8221
- MR8222 exp 7/31/2017
- MR10260
- exp 9/30/2017
- MR10926
- exp 10/31/2017
- b) MR6187
- exp 5/31/2017
- MR7302
- exp 6/30/2017
- MR7768
- MR7769
- exp 7/31/2017
- MR8247
- MR8887
- MR8892
- MR8893 exp 8/31/2017
- MR9014
- MR10414 exp 9/30/2017
- MR10928
Distribution
Distributed nationwide across the United States.
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