The Recall Desk

Manufacturer

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

22 recalls in our database name Mylan Institutional, Inc. (d.b.a. UDL Laboratories) as the manufacturing or recalling firm.

What the numbers show

Total
22
Critical
1
Severe
8
Most recent
2022-05-18

Of the 22 recalls from Mylan Institutional, Inc. (d.b.a. UDL Laboratories) we have scored against our rubric, 1 (5%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (36%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–22 of 22

  • HighFDA (Drugs)·D-0860-2022·2022-05-18

    Esomeprazole magnesium delayed-release capsules recalled for impurity specification failure

    Mylan Institutional Inc. is recalling Esomeprazole Magnesium Delayed-Release Capsules 20 mg due to failed impurity specifications detected during stability testing. 555 cartons of affected lots were distributed nationwide.

    Product
    Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-009-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0861-2022·2022-05-18

    Esomeprazole Magnesium Delayed-Release Capsules Recalled for Failed Quality Specifications

    Mylan Institutional is recalling Esomeprazole Magnesium Delayed-Release Capsules 40 mg due to failed impurity specifications found during stability testing, affecting 885 cartons nationwide.

    Product
    Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Capsules each per carton), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC 42292-010-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1013-2019·2019-03-27

    Mylan Recalls Alprazolam Tablets Due to Elevated Impurity Levels

    Mylan Institutional, Inc. is recalling specific lots of Alprazolam Tablets, 0.25 mg, because elevated levels of a known impurity were detected during stability testing.

    Product
    Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1112-2018·2018-08-29

    Mylan Recalls Diltiazem HCl Extended-release Capsules Due to Impurities

    Mylan Institutional, Inc. is recalling 408 cartons of Diltiazem HCl Extended-release Capsules, 120 mg, due to out-of-specification impurities.

    Product
    Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0822-2018·2018-05-30

    Mylan Recalls Loxapine Capsules Due to Cross-Contamination Risk

    Mylan Institutional, Inc. is recalling Loxapine Capsules 25 mg due to cGMP violations that create a risk of cross-contamination.

    Product
    Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0823-2018·2018-05-30

    Mylan Recalls Loxapine Capsules Due to Cross-Contamination Risk

    Mylan Institutional, Inc. is recalling Loxapine Capsules 50 mg due to cGMP violations that create a risk of cross-contamination.

    Product
    Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0622-2017·2017-04-05

    Mylan Recalls Atorvastatin Calcium Tablets Due to Microbial Contamination

    Mylan Institutional, Inc. is recalling 1,527 cartons of Atorvastatin Calcium 10 mg tablets due to potential microbial contamination and elevated bioburden.

    Product
    ATORVASTATIN CALCIUM — ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0136-2017·2016-11-16

    Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

    Mylan Institutional is recalling specific lots of Clonazepam 1.0 mg tablets because a known impurity exceeded specification limits during stability testing.

    Product
    Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505, NDC 51079-882-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0135-2017·2016-11-16

    Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

    Mylan Institutional, Inc. is recalling specific lots of Clonazepam Tablets, USP, 0.5 mg because they failed impurity specifications.

    Product
    Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and b) 300-count unit dose box of 10 x 30 punch cards (NDC 51079-881-56), Rx only, Manufactured by Mylan Pharmaceuticals Inc, Morgantown, WV, 26505
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1466-2016·2016-08-31

    Mylan Amlodipine Tablets Recalled for CGMP Deviations

    Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-450-20 and b) 30-count tablets per dosage card in a carton, NDC 51079-450-63, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Package
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1468-2016·2016-08-31

    Mylan Amlodipine Tablets Recalled for CGMP Deviations

    Mylan Institutional is recalling Amlodipine Besylate Tablets 10 mg because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-452-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-452-56; and c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-452-19; Rx
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1467-2016·2016-08-31

    Mylan Amlodipine Besylate Tablets Recalled for CGMP Deviations

    Mylan Institutional, Inc. is recalling Amlodipine Besylate Tablets, 5 mg, because they were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451-20; b) 300-count (10 x 30) unit dose blisters per carton, NDC 51079-451-56, c) 25-count (25 x 1) Robot-Rx Ready Packages in a carton, NDC 51079-451-19; and d)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0650-2016·2016-02-10

    Mylan Recalls Clonazepam Tablets Due to Impurity Specification Failure

    Mylan Institutional, Inc. is recalling Clonazepam Tablets, 0.5 mg, because a known impurity exceeded specifications at the 6-month timepoint.

    Product
    Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV, 26505, NDC:51079-881-21
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0235-2016·2015-11-25

    Mylan Recalls Meclizine Hydrochloride Tablets Due to Impurity Failures

    Mylan Institutional is recalling 4,609 packages of Meclizine Hydrochloride 25 mg tablets because they failed impurity specifications.

    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.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1083-2015·2015-05-27

    Mylan Recalls Fexofenadine Hydrochloride Tablets Due to Impurity Levels

    Mylan Institutional, Inc. is recalling 1,363 cartons of Fexofenadine Hydrochloride 60 mg tablets because routine stability testing showed slightly above specification results for a related compound.

    Product
    Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, USA, NDC 51079-547-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0377-2015·2015-01-28

    Mylan Recalls Ciprofloxacin Tablets Due to Manufacturing Deviations

    Mylan Institutional, Inc. is recalling Ciprofloxacin Tablets 500 mg because they were produced with active ingredients not manufactured according to Good Manufacturing Practices.

    Product
    CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-182-20.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0378-2015·2015-01-28

    Mylan Lamotrigine Tablets Recalled for CGMP Deviations

    Mylan Institutional is recalling 3,993 cartons of Lamotrigine 200 mg tablets because they were not manufactured according to Good Manufacturing Practices.

    Product
    LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV --- NDC 51079-866-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1435-2014·2014-07-23

    Mylan Recalls Diltiazem HCl Extended-Release Capsules Due to Impurities

    Mylan Institutional, Inc. is recalling Diltiazem HCl Extended-Release Capsules, 120 mg, due to high out-of-specification results for a related compound found during routine stability testing.

    Product
    Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 51079-947-08.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1155-2014·2014-03-19

    Mylan Recalls Carisoprodol Tablets Due to Failed Impurity Specification

    Mylan Institutional, Inc. is recalling 3,252 cartons of Carisoprodol Tablets, USP, 350 mg, because the product failed an impurity or degradation specification.

    Product
    Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-452-2013·2013-05-29

    Mylan Recalls Budesonide Capsules Due to Dissolution Testing Failures

    Mylan Institutional, Inc. is recalling 1,621 boxes of Budesonide Capsules, 3 mg, because routine stability testing showed out-of-specification dissolution results.

    Product
    Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) per box, Rx only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV 26505; Packaged and Distributed by: UDL Laboratories, Inc., Rockford, IL 61103, ND
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-166-2013·2013-02-27

    UDL Recalls Hydrocodone and Acetaminophen Tablets Due to Potency Issues

    Mylan Institutional, Inc. is recalling specific lots of Hydrocodone Bitartrate and Acetaminophen Tablets because the tablets are oversized, resulting in superpotent assays of both active ingredients.

    Product
    Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by & Distributed by UDL Laboratories, Inc.,
    Category
    Drug
    Distribution
    Distributed nationwide