Divalproex Sodium Tablets (Major Pharmaceuticals) – Humidity Exposure (2019)
Class II: 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
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
Brand
MAJOR PHARMACEUTICALS
Lot Codes / Batch Numbers
Lot# M02250 EXP 10/2020.
Products Sold
Lot# M02250 EXP 10/2020.
MAJOR PHARMACEUTICALS is recalling DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only due to cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026