Divalproex Sodium recalls: 8 FDA reports
Recalls involving Divalproex Sodium. What was wrong with each batch, and how the FDA graded the risk.
8Reports
0Class I
0Ongoing
2024-04-03Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmace
D-0426-2024 · Class II · reported 2024-04-03 · Terminated
- Why it was recalled
- Failed dissolution specifications
- Product
- Divalproex Sodium Extended-release Tablets, USP 250 mg, Rx Only, 100 tablets, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 65162-755-10. NDC# 65162-755-10
- Where it went
- Product was distributed nationwide.
- How much
- 21,452/100 count bottles
Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured b
D-1362-2022 · Class II · reported 2022-08-31 · Terminated
- Why it was recalled
- Failed dissolution specifications.
- Product
- Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
- Where it went
- USA nationwide
- How much
- 4,309 bottles
Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical
D-1291-2022 · Class II · reported 2022-08-03 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: Failure occurred during routine stability testing of dissolution test.
- Product
- Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol- 389 350, Gujarat, India, NDC 62756-798-88.
- Where it went
- Nationwide in the USA
- How much
- 9552 bottles
DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufact
D-1583-2019 · Class II · reported 2019-08-07 · Terminated
- Why it was recalled
- cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
- Product
- DIVALPROEX SODIUM EXTENDED-RELEASE TABLETS, USP Tablets, 250 mg, 100 count-unit dose carton, RX only, Manufactured by Dr. Reddy's Laboratories Ltd. Bachupally - 500 090 India. Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152. NDC # 0904-6363-61.
- Where it went
- Nationwide in the USA
- How much
- 828 100-count unit dose cartons
Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laborat
D-0507-2019 · Class II · reported 2019-02-27 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: Out of specification results observed for high dissolution.
- Product
- Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01
- Where it went
- U.S.A. Nationwide
- How much
- 10,656 bottles
Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Lab
D-0228-2018 · Class II · reported 2018-01-24 · Terminated
- Why it was recalled
- Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
- Product
- Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01
- Where it went
- Product was distributed nationwide in the USA.
- How much
- 96,876 Bottles of 30s
Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Lab
D-1136-2015 · Class II · reported 2015-06-24 · Terminated
- Why it was recalled
- Failed Dissolution Specifications; exceeded specification at the 9 hour time point
- Product
- Divalproex Sodium Extended-Release Tablets, USP, 500 mg, 100 count bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited Bachupally 500 090 India --- NDC 55111-534-01
- Where it went
- Nationwide
- How much
- 5,160 bottles
Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01
D-1135-2015 · Class II · reported 2015-06-24 · Terminated
- Why it was recalled
- Failed Dissolution Specifications; exceeded specification at the 9 hour time point
- Product
- Divalproex Sodium Extended-Release Tablets, USP, (valproic acid activity), 250 mg, 100 count (NDC 55111-533-01) and 500 count (NDC 55111-533-05) bottles, Rx Only, Mfd. By. Dr. Reddy's Laboratories Limited, Bachupally 500 090 India
- Where it went
- Nationwide
- How much
- 100 count 7479; 500 count - 2544
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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