FDA Drug recall D-0096-2023
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 597…
- FDA Drug
- Class III
- terminated
- Published 2023-01-11
On 2023-01-11 the FDA classified a Class III recall of Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 597… by Jubilant Cadista Pharmaceuticals, citing subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0096-2023 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2022-12-27 |
| Published | 2023-01-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jubilant Cadista Pharmaceuticals |
| Distribution | US |
Product
Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 59746-113-06
Reason
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Identifiers
| ndc | 59746-113-06 |
|---|---|
| ndc | 59746-113-10 |
| ndc | 59746-115-06 |
| ndc | 59746-115-10 |
| code_info | Lot#: 21P0336, Exp: 04/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Jubilant Cadista Pharmaceuticals
- Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: Jubilant Generics Ltd
FDA Drug · Class II · 2022-08-03 · Jubilant Cadista Pharmaceuticals - Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: Jubilant Generics Ltd
FDA Drug · Class II · 2022-08-03 · Jubilant Cadista Pharmaceuticals - Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured by: Jubliant Cadista Pharmaceuticals Inc
FDA Drug · Class III · 2022-04-13 · Jubilant Cadista Pharmaceuticals - Meclizine Hydrochloride Tablets USP, 12.5 mg, packaged in a case of 24 bottles (100-count bottle), Rx only, Manufactured by: Jubilant Cadis…
FDA Drug · Class I · 2022-04-06 · Jubilant Cadista Pharmaceuticals - Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd
FDA Drug · Class III · 2021-09-08 · Jubilant Cadista Pharmaceuticals
All Jubilant Cadista Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0096-2023%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.