Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

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

FDA Drug Recall #D-1043-2017 — Class II — May 10, 2017

Recall Summary

Recall Number D-1043-2017
Classification Class II — Moderate risk
Date Initiated May 10, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zydus Pharmaceuticals USA Inc
Location Pennington, NJ
Product Type Drugs
Quantity 108,726 HDPE bottles

Product Description

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

Reason for Recall

Failed Dissolution Specifications

Distribution Pattern

Nationwide

Lot / Code Information

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

Other Recalls from Zydus Pharmaceuticals USA Inc

Recall # Classification Product Date
D-0834-2020 Class II Ethacrynate Sodium for Injection, USP, 50mg/via... Jan 31, 2020
D-1453-2019 Class II MethylPREDNISolone Tablets, USP 8 mg, 25 tablet... May 6, 2019
D-1441-2019 Class II Anastrozole Tablets, USP, 1 mg, 1,000-count bot... May 6, 2019
D-1448-2019 Class II MethylPREDNISolone Tablets, USP, 4 mg, 100 tabl... May 6, 2019
D-1446-2019 Class II Pramipexole Dihydrochloride Tablets 0.5 mg, 90-... May 6, 2019

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.

More from Zydus Pharmaceuticals ... Recalls by Firm Recall Reasons Drug Safety Stats