Zydus Divalproex Tablets Recall: Failed Dissolution Specifications
Zydus Pharmaceuticals USA recalls 250mg and 500-count Divalproex Sodium Delayed Release Tablets due to failed dissolution specifications. This may affect medication effectiveness.
Lower-risk recall
Failed Dissolution Specifications
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What happened, in plain English
Zydus Pharmaceuticals USA is recalling certain Divalproex Sodium Delayed Release Tablets because they failed dissolution specifications. This could mean the medication doesn't work properly when taken as intended. Read more at govinfonow.com/recall/41626-zydus-divalproex-tablets-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/41626-zydus-divalproex-tablets-recall-failed-dissolution-specifications · Updated October 8, 2026 · FDA enforcement record: FDA #D-1042-2017
Cite this page
“Zydus Divalproex Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41626-zydus-divalproex-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-1042-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1042-2017%22&limit=1).
Why it’s dangerous
The tablets failed to dissolve properly as they should, which could lead to inconsistent medication levels in the body. This might not cause immediate harm but could affect treatment effectiveness over time.
Who’s affected
People who have the 250 mg 100-count bottle (NDC 68382-032-01) or 500-count bottle (NDC 68382-032-05) of Divalproex Sodium Delayed Release Tablets. Those taking this medication for conditions like seizures or bipolar disorder are most at risk.
How to tell if you have this one
Check for the 250 mg 100-count bottle (NDC 68382-032-01) or 500-count bottle (NDC 68382-032-05) with the manufacturer's name Cadila Healthcare Ltd, Ahmedabad, India.
- Brand
Zydus- Category
Drug
All 3 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 number | Product, codes & lots | Quantity |
|---|---|---|
| D-1041-2017 | Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01; MR6317 Exp.05/17 MR6318 Exp. 05/17 MR6319 Exp. 05/17 MR5361 Exp. 06/17 MR9007 Exp. 08/17 MR10000 Exp. 08/17 MR10923 Exp. 10/17 MR10924 Exp. 10/17 MR10925 Exp. 10/17 MR11554 Exp. 11/17 MR11555 Exp. 11/17 MS1359 Exp. 12/17 | 108,096 HDPE bottles |
| D-1042-2017 | Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054; MR5990 May-17 MR5991 May-17 MR7294 Jun-17 MR7295 Jun-17 MR7296 Jun-17 MR7297 Jun-17 MR7298 Jun-17 MR7603 Jun-17 MR7604 Jun-17 MR7605 Jun-17 MR7606 Jul-17 MR7607 Jul-17 MR8575 Aug-17 MR8576 Aug-17 MR8577 Aug-17 MR8882 Aug-17 MR8883 Aug-17 MR8884 Aug-17 MR8885 Aug-17 MR8886 Aug-17 MR9417 Aug-17 MR9418 Aug-17 MR9419 Aug-17 MR9499 Aug-17 MR9500 Aug-17 MR9501 Sep-17 MR9502 Sep-17 MR9601 Sep-17 MR9602 Sep-17 MR9805 Sep-17 MR9806 Sep-17 MR9807 Sep-17 MR9808 Sep-17 MR10536 Oct-17 MR10537 Oct-17 MR10538 Oct-17 MR10539 Oct-17 MR10540 Oct-17 MR10916 Oct-17 MR10918 Oct-17 MR10919 Nov-17 MR10920 Nov-17 MR10921 Nov-17 MR11366 Nov-17 MR11367 Nov-17 MR11368 Nov-17 MR11369 Nov-17 MR11370 Nov-17 MR11671 Nov-17 MR11672 Nov-17 MR11682 Nov-17 MR11682 Nov-17 MS1360 Dec-17 MS1361 Dec-17 MS1362 Dec-17 MS1363 Dec-17 MS1364 Dec-17 M600386 Feb-18 M600387 Feb-18 M600388 Feb-18 M602270 Mar-18 M602272 Apr-18 | 115,122 HDPE bottles |
| D-1043-2017 | Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054; M603084 May-18 M603085 May-18 M603679 May-18 MR10030 Sep-17 MR10040 Sep-17 MR10103 Sep-17 MR10104 Sep-17 MR10259 Sep-17 MR10262 Sep-17 MR10263 Sep-17 MR10413 Sep-17 MR10415 Sep-17 MR10416 Oct-17 MR10695 Oct-17 MR10696 Oct-17 MR10697 Oct-17 MR10698 Oct-17 MR10699 Oct-17 MR10927 Oct-17 MR10929 Oct-17 MR10930 Nov-17 MR11182 Nov-17 MR11184 Nov-17 MR11187 Oct-17 MR11188 Oct-17 MR11189 Nov-17 MR11190 Nov-17 MR11361 Nov-17 MR11362 Nov-17 MR11363 Nov-17 MR11364 Nov-17 MR11365 Nov-17 MR11673 Nov-17 MR11674 Nov-17 MR11675 Nov-17 MR11676 Nov-17 MR11677 Nov-17 MR11872 Nov-17 MR11873 Nov-17 MR11874 Nov-17 MR11875 Nov-17 MR11876 Nov-17 MR11877 Nov-17 MR11878 Nov-17 MR5992 May-17 MR6188 May-17 MR6189 May-17 MR6313 May-17 MR6314 Jun-17 MR6315 Jun-17 MR6316 Jun-17 MR6620 Jun-17 MR6621 Jun-17 MR6622 Jun-17 MR7031 Jun-17 MR7032 Jun-17 MR7033 Jun-17 MR7034 Jun-17 MR7035 Jun-17 MR7299 Jun-17 MR7300 Jun-17 MR7301 Jun-17 MR7303 Jun-17 MR7767 Jul-17 MR8223 Jul-17 MR8224 Jul-17 MR8225 Jul-17 MR8248 Jul-17 MR8249 Jul-17 MR8578 Aug-17 MR8579 Aug-17 MR8580 Aug-17 MR8581 Aug-17 MR8888 Aug-17 MR8889 Aug-17 MR8890 Aug-17 MR8891 Aug-17 MR8894 Aug-17 MR9012 Aug-17 MR9013 Sep-17 MR9015 Sep-17 MR9016 Sep-17 MR9414 Aug-17 MR9415 Aug-17 MR9416 Sep-17 MS1246 Dec-17 MS1247 Dec-17 MS1248 Dec-17 MS1249 Dec-17 MS1250 Dec-17 MS1251 Dec-17 MS1252 Dec-17 MS1355 Dec-17 MS1356 Dec-17 MS1357 Jan-18 MS1358 Dec-17 MS2490 Feb-18 MS2491 Feb-18 MS2492 Feb-18 | 108,726 HDPE bottles |
What to do — step by step
Check Product Details
Look for the NDC codes 68382-032-01 or 68382-032-05 on the bottle label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.7 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-1042-2017 (May 10, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1042-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.