Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) has 22 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 18 May 2022. The most frequent reason is potency & assay.

Total recalls22since 2013

Last 12 months0reported

Class I15% of total

Ongoing0latest 18 May 2022

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 1 5%Class II 12 55%Class III 9 41%

Why mylan institutional, inc. (d.b.a. udl laboratories) is recalled

Product types

Brands

Atorvastatin Calcium15%
Mirtazapine15%

By year

202229%
201915%
2018314%
201729%
2016627%
2015418%
201429%
201329%

All mylan institutional, inc. (d.b.a. udl laboratories) recalls, newest first

22 total

Reported	Class	Recall	Company	Reason	Where
18 May 2022Drug	CLASS II	Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg recalled	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
18 May 2022Drug	CLASS II	Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg recalled	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
27 Mar 2019Drug	CLASS II	Alprazolam Tablets, USP, 0.25 mg recalled by Mylan Institutional, Inc.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
29 Aug 2018Drug	CLASS III	Diltiazem HCl Extended-release Capsules, USP 120 mg recalled	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
30 May 2018Drug	CLASS II	Loxapine Capsules, USP 25 mg recalled by Mylan Institutional, Inc.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Manufacturing (CGMP) Deviations	Nationwide
30 May 2018Drug	CLASS II	Loxapine Capsules, USP 50 mg recalled by Mylan Institutional, Inc.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Manufacturing (CGMP) Deviations	Nationwide
5 Apr 2017Drug	CLASS II	Atorvastatin Calcium Tablets, 10 mg* Unit Dose Tablets (10 recalledAtorvastatin Calcium	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Sterility	Nationwide
15 Mar 2017Drug	CLASS II	Mirtazapine Tablets, USP, 45 mg recalled by Mylan Institutional, Inc.Mirtazapine	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Other	Nationwide
16 Nov 2016Drug	CLASS III	Clonazepam Tablets, USP, 0.5 mg recalled by Mylan Institutional, Inc.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
16 Nov 2016Drug	CLASS III	Clonazepam Tablets, USP, 1.0 mg recalled by Mylan Institutional, Inc.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
31 Aug 2016Drug	CLASS II	Amlodipine Besylate Tablets, USP, 2.5 mg* recalled	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Manufacturing (CGMP) Deviations	Nationwide
31 Aug 2016Drug	CLASS II	Amlodipine Besylate Tablets, USP, 10 mg* recalled	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Manufacturing (CGMP) Deviations	Nationwide
31 Aug 2016Drug	CLASS II	Amlodipine Besylate Tablets, USP, 5 mg* recalled	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Manufacturing (CGMP) Deviations	Nationwide
10 Feb 2016Drug	CLASS III	Clonazepam Tablets, USP, 0.5 mg recalled by Mylan Institutional, Inc.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
25 Nov 2015Drug	CLASS III	Meclizine Hydrochloride Tablets recalled by Mylan Institutional, Inc.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
27 May 2015Drug	CLASS III	Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy recalled	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
28 Jan 2015Drug	CLASS II	Lamotrigine Tablets, 200 mg per blister card x 10 blister recalled	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Manufacturing (CGMP) Deviations	Nationwide
28 Jan 2015Drug	CLASS II	Ciprofloxacin Tablets, USP, 500 mg per blister card recalled	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Manufacturing (CGMP) Deviations	Nationwide
23 Jul 2014Drug	CLASS III	Diltiazem HCl Extended-release Capsules, USP, 120 mg recalled	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
19 Mar 2014Drug	CLASS III	Carisoprodol Tablets, USP, 350 mg recalled by Mylan Institutional, Inc.	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
29 May 2013Drug	CLASS III	Budesonide Capsules, 3 mg, Enteric Coated recalled	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide
27 Feb 2013Drug	CLASS I	Hydrocodone Bitartrate and Acetaminophen Tablets recalled	Mylan Institutional, Inc. (d.b.a. UDL Laboratories)	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.