ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg — Class I drug recall D-0893-2023
Terminated recall by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, reported 2023-06-28, distributed nationwide. Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to c
| Recall number | D-0893-2023 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories, La Vergne, TN, United States |
| Recall initiated | 2023-05-31 |
| Classified | 2023-07-05 |
| Reported by FDA | 2023-06-28 |
| Terminated | 2024-07-02 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| NDC | 00904-6269, 00904-6269-08, 00904-6269-45, 00904-6270, 00904-6270-08, 00904-6270-45, 00904-6271, 00904-6271-08, 00904-6271-45, 00904-6272, 00904-6272-08, 00904-6272-45 |
| Lot numbers | 2024/12, T04769 |
Product
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally-500 090 India, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-6269-08
Reason for recall
Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0893-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.