Prochlorperazine Maleate Tablets — Class III drug recall D-0096-2023
Terminated recall by Jubilant Cadista Pharmaceuticals, Inc., reported 2023-01-11, distributed nationwide. Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
| Recall number | D-0096-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, United States |
| Recall initiated | 2022-12-27 |
| Classified | 2023-01-05 |
| Reported by FDA | 2023-01-11 |
| Terminated | 2023-12-05 |
| Distributed | Nationwide (US) |
| Quantity | 14,061 bottles |
| Reason classes | potency, specification failure |
| NDC | 59746-0113, 59746-0113-06, 59746-0113-10, 59746-0115, 59746-0115-06, 59746-0115-10 |
| Lot numbers | 21P0336 |
| Expiration dates | 2023-04 |
Product
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
Reason for recall
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
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-0096-2023. 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.