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Drug recall · FDA · Published May 22, 2015

Dr. Reddy's Laboratories, Inc. recalls Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories

Failed Dissolution Specifications; exceeded specification at the 9 hour time point

🇺🇸 FDA recall #D-1136-2015DrugDr. Reddy's Laboratories, Inc. ›
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Recalling firmDr. Reddy's Laboratories, Inc.107 College Rd E · Princeton, NJ 08540-6623
No email on file for this recall — reach the company by phone or its official page instead.No email on file — write to the address above instead.
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Source Page by GovInfoNow · govinfonow.com/recall/44669-dr-reddy-s-laboratories-inc-recalls-divalproex-sodium-extended-release · Recall date May 22, 2015 · FDA enforcement record: FDA #D-1136-2015

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“Dr. Reddy's Laboratories, Inc. recalls Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories.” GovInfoNow, recall dated May 22, 2015. https://govinfonow.com/recall/44669-dr-reddy-s-laboratories-inc-recalls-divalproex-sodium-extended-release. Based on FDA recall #D-1136-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1136-2015%22&limit=1).

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  • Brand
    Dr. Reddy's Laboratories, Inc.
  • Category
    Drug
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide
Recall numberProduct, codes & lotsQuantityNDC
D-1135-2015Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India; 100 count bottle - Lot #C307859, exp 09/2015; 500 count bottle - Lot #C307859 and Lot# C307812, exp 09/2015100 count 7479; 500 count - 254455111-533-30, 55111-533-60, 55111-533-01, 55111-533-05, 55111-533-79, 55111-533-78
D-1136-2015Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01; Lot #C308195, exp 10/20155,160 bottles55111-534-30, 55111-534-60, 55111-534-01, 55111-534-05
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Contact Dr. Reddy's Laboratories, Inc.

We’ve drafted a message you can send Dr. Reddy's Laboratories, Inc. to request your refund or repair — edit it as you like.

Subject: Recall D-1136-2015 — Dr. Reddy's Laboratories, Inc. Dr. Reddy's Laboratories, Inc. recalls Divalproex Sodium Extended-Re

Hello,

I own a Dr. Reddy's Laboratories, Inc. recalls Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories that is covered by recall D-1136-2015 from Dr. Reddy's Laboratories, Inc..

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-1136-2015 (May 22, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1136-2015 to see it in context.
  • 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA