CLASS II Drug recall · Reported 5 Apr 2017 · FDA Enforcement Report

Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) recalled

Zydus Pharmaceuticals USA is recalling Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) (, distributed nationwide in the US. The recall was initiated on 15 Mar 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) MR8221, MR8222 exp 7/31/2017; MR10260, exp 9/30/2017; MR10926, exp 10/31/2017; b) MR6187, exp 5/31/2017; MR7302, exp 6/30/2017; MR7768, MR7769, exp 7/31/2017; MR8247, exp 7/31/2017; MR8887, MR8892, MR8893 exp 8/31/2017; MR9014, MR10414 exp 9/30/2017; MR10928, exp 10/31/2017; MR11183, MR11185, MR11186, exp 11/30/2017

Quantity recalled32628 bottles

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-0617-2017
FDA event ID: 76737
Recalling firm: Zydus Pharmaceuticals USA, Pennington, NJ
Classification: Class II
Status: Terminated
Recall initiated: 15 Mar 2017
FDA classified: 27 Mar 2017
Reported: 5 Apr 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Seizure Medication

Timeline

15 Mar 2017	Recall initiated by company
27 Mar 2017	Classified by FDA	+12 days
5 Apr 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; 9 month long term stability

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 (NDC 68382-033-01) and b) 500 count (NDC 68382-033-05) bottles, Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ

Where it was distributed

Nationwide

Questions about this recall

Is Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) ( recalled?

Yes. Zydus Pharmaceuticals USA recalled Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a) ( on 15 Mar 2017. The recall is Class II and its status is Terminated. Recall number D-0617-2017.

Why was it recalled?

Failed Dissolution Specifications; 9 month long term stability

Which lots are affected?

a) MR8221, MR8222 exp 7/31/2017; MR10260, exp 9/30/2017; MR10926, exp 10/31/2017; b) MR6187, exp 5/31/2017; MR7302, exp 6/30/2017; MR7768, MR7769, exp 7/31/2017; MR8247, exp 7/31/2017; MR8887, MR8892, MR8893 exp 8/31/2017; MR9014, MR10414 exp 9/30/2017; MR10928, exp 10/31/2017; MR11183, MR11185, MR11186, exp 11/30/2017

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

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Other Divalproex recalls

All 16

Reported	Class	Recall	Company	Reason	Where
29 Jul 2026Drug	CLASS II	Divalproex Sodium Delayed-Release Tablets, USP, 500 mg recalledDivalproex Sodium	Bionpharma	Other	Nationwide
3 Apr 2024Drug	CLASS II	Divalproex Sodium Extended-release Tablets, USP 250 mg recalledDivalproex Sodium	Amneal Pharmaceuticals of New York	Potency & Assay	Nationwide
31 Aug 2022Drug	CLASS II	Divalproex Sodium Extended Release Tablets, USP, 250 mg recalledDivalproex Sodium	Amneal Pharmaceuticals of New York	Potency & Assay	Nationwide
3 Aug 2022Drug	CLASS II	Divalproex Sodium Delayed-Release Tablets, USP 500mg recalledDivalproex Sodium	Sun Pharmaceutical Industries	Potency & Assay	Nationwide
7 Aug 2019Drug	CLASS II	Divalproex Sodium Extended-release Tablets, USP Tablets recalledDivalproex Sodium	Major Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide