CLASS II Drug recall · Reported 9 Aug 2017 · FDA Enforcement Report
Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) bottle recalled
Zydus Pharmaceuticals USA is recalling Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 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-1043-2017
- 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, 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
Where it was distributed
Nationwide
Questions about this recall
Is Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) bottle ( recalled?
Yes. Zydus Pharmaceuticals USA recalled Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) bottle ( on 10 May 2017. The recall is Class II and its status is Terminated. Recall number D-1043-2017.
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
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
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 |