MAJOR PHARMACEUTICALS recalls DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by
Major Pharmaceuticals recalls 250mg Divalproex Sodium Extended-Release Tablets due to potential moisture exposure during packaging, which may affect stability. Affected units include specific lot numbers and distribution dates.
Lower-risk recall
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
Contact the company & request your remedy
What happened, in plain English
Major Pharmaceuticals is recalling 250mg Divalproex Sodium Extended-Release Tablets that may have been exposed to high humidity during manufacturing. This could potentially affect the tablet's stability, though the recall does not specify immediate safety risks. Read more at govinfonow.com/recall/38881-major-pharmaceuticals-divalproex-sodium-extended-release-tablets-recall-humidity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38881-major-pharmaceuticals-divalproex-sodium-extended-release-tablets-recall-humidity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1583-2019
Cite this page
“Major Pharmaceuticals Divalproex Sodium Extended-Release Tablets Recall: Humidity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38881-major-pharmaceuticals-divalproex-sodium-extended-release-tablets-recall-humidity-risk. Based on FDA recall #D-1583-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1583-2019%22&limit=1).
Why it’s dangerous
The tablets were exposed to humidity levels above 50% during packaging, which could lead to moisture absorption. This might affect the tablet's stability and effectiveness, but the recall does not indicate immediate safety hazards.
Who’s affected
Prescription patients who received the specific lot number (M02250) of Divalproex Sodium Extended-Release Tablets from Major Pharmaceuticals. Patients using this medication for seizure control or mood disorders are most at risk if the tablets degrade.
How to tell if you have this one
Check for the lot number M02250 on the packaging, which expires October 2020. The product is a 250mg Divalproex Sodium Extended-Release Tablet, 100-count unit dose carton, manufactured by Dr. Reddy's Laboratories Ltd. in India.
- Brand
Major Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number M02250 and expiration date of October 2020 on the packaging.
Questions people ask
Why is this product being recalled?
The product was exposed to humidity levels above 50% during packaging, which could affect its stability.
What should I do if I have this product?
The recall does not specify a remedy; check the lot number and contact your healthcare provider for guidance.
Is this product safe to use?
The recall does not indicate immediate safety risks, but the product may not be stable if exposed to high humidity.
Contact Major Pharmaceuticals
We’ve drafted a message you can send Major Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1583-2019 — Major Pharmaceuticals Major Pharmaceuticals Hello, I own a Major Pharmaceuticals that is covered by recall D-1583-2019 from Major Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1583-2019 (April 24, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1583-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.