FDA Drug recall D-0082-2018
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salis…
- FDA Drug
- Class III
- terminated
- Published 2017-11-22
On 2017-11-22 the FDA classified a Class III recall of Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salis… by Jubilant Cadista Pharmaceuticals, citing marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0082-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2017-10-30 |
| Published | 2017-11-22 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Jubilant Cadista Pharmaceuticals |
| Distribution | US |
Product
Meclizine hydrochloride tablets USP, 12.5 mg, 100 count HDPE bottle, Rx only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-122-06
Reason
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Identifiers
| ndc | 59746-122-06 |
|---|---|
| ndc | 59746-122-10 |
| ndc | 59746-121-06 |
| ndc | 59746-121-10 |
| code_info | Lot # 17P0430, Exp 05/19 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Jubilant Cadista Pharmaceuticals
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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-0082-2018%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.