CLASS II Drug recall · Reported 9 Aug 2017 · FDA Enforcement Report
Divalproex Sodium Delayed Release Tablets, USP, 250 mg bottle recalled
Zydus Pharmaceuticals USA is recalling Divalproex Sodium Delayed Release Tablets, USP, 250 mg bottle (, distributed nationwide in the US. The recall was initiated on 10 May 2017 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1042-2017
- FDA event ID
- 77674
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 May 2017
- FDA classified
- 31 Jul 2017
- Reported
- 9 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Seizure Medication
Timeline
| 10 May 2017 | Recall initiated by company | |
| 31 Jul 2017 | Classified by FDA | +82 days |
| 9 Aug 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Is Divalproex Sodium Delayed Release Tablets, USP, 250 mg bottle ( recalled?
Yes. Zydus Pharmaceuticals USA recalled Divalproex Sodium Delayed Release Tablets, USP, 250 mg bottle ( on 10 May 2017. The recall is Class II and its status is Terminated. Recall number D-1042-2017.
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
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
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Zydus Pharmaceuticals USA
All 95| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mirabegron Extended-Release Tablets, 25 mg recalledMirabegron | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 250 mg recalledErythromycin | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Erythromycin Tablets, USP, 500 mg recalledErythromycin | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Icosapent Ethyl Capsules recalled by Zydus Pharmaceuticals (USA)Icosapent Ethyl | Zydus Pharmaceuticals (USA) | Other | Nationwide |
| Drug | CLASS II | Icosapent Ethyl capsules recalled by Zydus Pharmaceuticals (USA) | Zydus Pharmaceuticals (USA) | Potency & Assay | Nationwide |
Other Divalproex recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg recalledDivalproex Sodium | Bionpharma | Other | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended-release Tablets, USP 250 mg recalledDivalproex Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended Release Tablets, USP, 250 mg recalledDivalproex Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Divalproex Sodium Delayed-Release Tablets, USP 500mg recalledDivalproex Sodium | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended-release Tablets, USP Tablets recalledDivalproex Sodium | Major Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |