CLASS II Drug recall · Reported 24 Jan 2018 · FDA Enforcement Report
Divalproex Sodium Delayed Release Tablets USP, 500 mg recalled
Unichem Pharmaceuticals Usa is recalling Divalproex Sodium Delayed Release Tablets USP, 500 mg, distributed nationwide in the US. The recall was initiated on 19 Dec 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-0228-2018
- FDA event ID
- 78786
- Recalling firm
- Unichem Pharmaceuticals Usa, Hasbrouck Heights, NJ
- Brand
- Divalproex Sodium
- Manufacturer
- Unichem Pharmaceuticals (USA), Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Dec 2017
- FDA classified
- 17 Jan 2018
- Reported
- 24 Jan 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Seizure Medication
Timeline
| 19 Dec 2017 | Recall initiated by company | |
| 17 Jan 2018 | Classified by FDA | +29 days |
| 24 Jan 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Product as listed by the FDA
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 was distributed
Product was distributed nationwide in the USA.
Questions about this recall
Is Divalproex Sodium Delayed Release Tablets USP, 500 mg recalled?
Yes. Unichem Pharmaceuticals Usa recalled Divalproex Sodium Delayed Release Tablets USP, 500 mg on 19 Dec 2017. The recall is Class II and its status is Terminated. Recall number D-0228-2018.
Why was it recalled?
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Which lots are affected?
Lot: ZDPH17040
Where was it sold?
Product was distributed nationwide in the USA.
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.
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|---|---|---|---|---|---|
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| Drug | CLASS I | Cyclobenzaprine Hydrochloride Tablets, USP, 10 mg recalledCyclobenzaprine Hydrochloride | Unichem Pharmaceuticals USA | Other | Nationwide |
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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 |