Meclizine hydrochloride tablets USP — Class III drug recall D-0082-2018
Terminated recall by Jubilant Cadista Pharmaceuticals, Inc., reported 2017-11-22, distributed nationwide. Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
| Recall number | D-0082-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD, United States |
| Recall initiated | 2017-10-30 |
| Classified | 2017-11-16 |
| Reported by FDA | 2017-11-22 |
| Terminated | 2020-02-12 |
| Distributed | Nationwide (US) |
| Quantity | 744 bottles |
| Reason classes | unapproved product |
| NDC | 59746-0121, 59746-0121-06, 59746-0121-10, 59746-0122, 59746-0122-06, 59746-0122-10 |
| Lot numbers | 05/19, 17P0430 |
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 for recall
Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
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-0082-2018. 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.