FDA Drug recall D-0228-2018
Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd
- FDA Drug
- Class II
- terminated
- Published 2018-01-24
On 2018-01-24 the FDA classified a Class II recall of Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd by Unichem Pharmaceuticals Usa, citing cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0228-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-12-19 |
| Published | 2018-01-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Unichem Pharmaceuticals Usa |
| Distribution | US |
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
Reason
Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Identifiers
| ndc | 29300-138-01 |
|---|---|
| ndc | 29300-138-05 |
| ndc | 29300-138-10 |
| ndc | 29300-139-01 |
| ndc | 29300-139-05 |
| ndc | 29300-139-10 |
| ndc | 29300-140-01 |
| ndc | 29300-140-05 |
| ndc | 29300-140-10 |
| code_info | Lot: ZDPH17040 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Unichem Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0228-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.