Meclizine Hydrochloride Tablets USP — Class III drug recall D-0234-2016
Terminated recall by Par Pharmaceutical Inc., reported 2015-11-25, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification for impurities.
| Recall number | D-0234-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Par Pharmaceutical Inc., Spring Valley, NY, United States |
| Recall initiated | 2015-10-26 |
| Classified | 2015-11-13 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2017-04-20 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 49884-0035-01, 49884-0035-10 |
| Lot numbers | 24502301, 24505901, 25552101, 25712701, 25787901, 25787902, 25960301, 26074601, 26074701, 26220001, 26259701, 26259801, 26575801, 26579001, 26579002, 26682801, 26682901, 26731702, 26731801, 26764801 |
| Expiration dates | 2015-10-20, 2016-08-20, 2016-09-20, 2016-11-20, 2017-01-20, 2017-03-20, 2017-04-20, 2017-06-20, 2017-09-20, 2017-11-20, 2018-03-20 |
Product
Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification for impurities.
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-0234-2016. 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.