Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count…
Medicine recall D-1042-2017. Published in FDA’s Enforcement Report on Aug 9, 2017.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Aug 9, 2017. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 115,122 HDPE bottles how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is 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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
Failed Dissolution Specifications
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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
115,122 HDPE bottles, in FDA’s words.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 891 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Barcodes and drug codes
-
NDC
68382-032-01 -
NDC
68382-032-05
As FDA’s description and codes give them; the UPCs written as digits only.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on May 10, 2017.
- FDA classified it on Jul 31, 2017.
- FDA’s Enforcement Report published it on Aug 9, 2017.
- FDA terminated it on Jan 7, 2020.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Zydus Pharmaceuticals USA Inc, of Pennington, NJ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Drug recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.