Major Pharmaceuticals Recalls Divalproex Sodium Tablets Due to Humidity Exposure
Major Pharmaceuticals is recalling 828 cartons of Divalproex Sodium Extended-Release Tablets because they were exposed to high humidity during packaging.
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 and involves a cGMP deviation (humidity exposure) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Major Pharmaceuticals is recalling 828 100-count unit dose cartons of Divalproex Sodium Extended-Release Tablets, 250 mg. The affected product is Lot # M02250 with an expiration date of 10/2020. The product was distributed nationwide in the USA.
The recall was initiated due to current Good Manufacturing Practice (cGMP) deviations. Specifically, the product was exposed to above 50% relative humidity levels during packaging operations. This exposure may affect the quality or stability of the medication.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund. The product is a prescription-only medication manufactured by Dr. Reddy's Laboratories Ltd. and distributed by Major Pharmaceuticals.
The recalled product
- Product
- DIVALPROEX SODIUM (DIVALPROEX SODIUM)
- Brand
- DIVALPROEX SODIUM
- Manufacturer
- MAJOR PHARMACEUTICALS
- Category
- Drug — Prescription Medication
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 (1)
- Lot# M02250 EXP 10/2020.
Distribution
Distributed nationwide across the United States.
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