Meclizine Hydrochloride Tablets — Class III drug recall D-0235-2016
Terminated recall by Mylan Institutional, Inc. (d.b.a. UDL Laboratories), reported 2015-11-25, distributed nationwide. Failed Impurities/Degradation Specifications: Out of specification for impurities.
| Recall number | D-0235-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL, United States |
| Recall initiated | 2015-11-02 |
| Classified | 2015-11-13 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2016-12-21 |
| Distributed | Nationwide (US) |
| Quantity | 4,609 packages |
| Reason classes | specification failure |
| NDC | 51079-0090-20 |
| Lot numbers | 3060153 |
| Expiration dates | 2016-08-31 |
Product
Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.
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-0235-2016. 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.