Reported Aug 9, 2017 · Terminated

Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle…

Zydus Pharmaceuticals USA Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zydus Pharmaceuticals USA Inc · 73 Route 31 N · Pennington, NJ · 08534-3601

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 byZydus Pharmaceuticals, Pennington, NJ 07054

Lot codes and dates: 198 of 198 codes
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
Amount recalled: 108,726 HDPE bottles

The agency filed one notice per product. You are reading one of them; the other 2 are below.

Failed Dissolution Specifications

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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23 in total.