FDA Drug recall D-0235-2016
Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only
- FDA Drug
- Class III
- terminated
- Published 2015-11-25
On 2015-11-25 the FDA classified a Class III recall of Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only by Mylan Institutional D B A Udl Laboratories, citing failed Impurities/Degradation Specifications: Out of specification for impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0235-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-11-02 |
| Published | 2015-11-25 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Institutional D B A Udl Laboratories |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: Out of specification for impurities.
Identifiers
| code_info | Lot #: 3060153, Expiry: 08/31/16 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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FDA Drug · Class II · 2022-05-18 · Mylan Institutional D B A Udl Laboratories - Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 5…
FDA Drug · Class II · 2019-03-27 · Mylan Institutional D B A Udl Laboratories - Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by:…
FDA Drug · Class III · 2018-08-29 · Mylan Institutional D B A Udl Laboratories - Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc
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All Mylan Institutional D B A Udl Laboratories recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0235-2016%22
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