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.
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.