Dr. Reddy's Laboratories, Inc. recalls Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle
Dr. Reddy's recalls 250mg Divalproex Sodium Extended-Release Tablets due to packaging humidity exposure. These tablets may degrade in high humidity, affecting safety.
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
Dr. Reddy's is recalling 250mg Divalproex Sodium Extended-Release Tablets that were exposed to high humidity during manufacturing. This could cause the tablets to degrade, potentially affecting their safety and effectiveness. Read more at govinfonow.com/recall/38938-dr-reddy-s-divalproex-tablets-recall-humidity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/38938-dr-reddy-s-divalproex-tablets-recall-humidity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1133-2019
Cite this page
“Dr. Reddy's Divalproex Tablets Recall: Humidity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38938-dr-reddy-s-divalproex-tablets-recall-humidity-risk. Based on FDA recall #D-1133-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1133-2019%22&limit=1).
Why it’s dangerous
The tablets were exposed to humidity levels above 50% during packaging, which could cause them to degrade. This degradation might affect the medication's safety and effectiveness, but the risk is not severe enough to cause serious injury.
Who’s affected
People who have the 250mg Divalproex Sodium Extended-Release Tablets in bottles labeled NDC 55111-0533-01 (100-count) or NDC 55111-0533-05 (500-count). Those with a prescription for this medication are most at risk.
How to tell if you have this one
Check for bottles labeled 'Divalproex Sodium Extended-Release Tablets, 250 mg' with NDC numbers 55111-0533-01 (100-count) or 55111-0533-05 (500-count). The product is prescription-only and has specific expiration dates.
- Brand
Dr. Reddy's- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC numbers 55111-0533-01 or 55111-0533-05 on the bottle label to confirm if it's recalled.
Questions people ask
Is this product safe to use?
The recall is due to potential degradation from humidity exposure, but the product is still safe to use if stored properly. However, the manufacturer recommends checking for the specific NDC numbers to confirm if it's recalled.
What should I do if I have this product?
The recall does not require immediate action, but you should check the NDC numbers to see if your product is affected. If it is, contact your doctor or pharmacist for advice.
How long is the product expected to last?
The product has specific expiration dates listed on the bottle (e.g., Exp. 03/2020), but the recall is about potential degradation during manufacturing, not the product's shelf life.
Contact Dr. Reddy's
We’ve drafted a message you can send Dr. Reddy's to request your refund or repair — edit it as you like.
Subject: Recall D-1133-2019 — Dr. Reddy's Dr. Reddy's Hello, I own a Dr. Reddy's that is covered by recall D-1133-2019 from Dr. Reddy's. 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-1133-2019 (April 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1133-2019 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.