FDA Drug recall D-1837-2019
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains…
- FDA Drug
- Class I
- terminated
- Published 2019-08-07
On 2019-08-07 the FDA classified a Class I recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains… by Jubilant Cadista Pharmaceuticals, citing failed dissolution specifications : failed results at the 3-month stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1837-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-07-09 |
| Published | 2019-08-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Jubilant Cadista Pharmaceuticals |
| Distribution | US |
Product
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.02 mg, packaged into a carton containing 3 blister cards each blister card contains 28-film coated, biconvex tablets, Rx Only, Manufactured by: Cyndea Pharma, S.L., Olvega (Soria), 42110 Spain, Distributed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, 21801 USA, NDC 59746-763-43
Reason
Failed dissolution specifications : failed results at the 3-month stability time point.
Identifiers
| code_info | Lot #: 183222, Exp 11/2020 |
|---|
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
- Prochlorperazine Maleate Tablets, USP 5mg, 100 tablets, RX Only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, Maryland 21801, NDC 597…
FDA Drug · Class III · 2023-01-11 · 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
All Jubilant Cadista Pharmaceuticals recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1837-2019%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.