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Mylan Institutional, Inc. (d.b.a. UDL Laboratories) Recalls
22 recalls on record · February 27, 2013 to May 18, 2022 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 18, 2022DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Esomeprazole Magnesium Delayed-Release Capsules, USP 40 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Caps
Hazard: Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
May 18, 2022DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Caps
Hazard: Failed Impurities/Degradation Specifications: OOS result was obtained for Any Other Individual Impurity at the 12M room temperature time point.
March 27, 2019DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, W
Hazard: Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.
August 29, 2018DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Onl
Hazard: Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer
May 30, 2018DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Mo
Hazard: GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
May 30, 2018DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Mo
Hazard: GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
April 5, 2017DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan
Hazard: Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identification of objectionable organisms.
March 15, 2017DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morganto
Hazard: Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled
November 16, 2016DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Clonazepam Tablets, USP, 1.0 mg, packaged in a 100- count unit dose box of 10 x 10 blister cards, Rx only, Manufactured
Hazard: Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 16 month timepoint.
November 16, 2016DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls 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
Hazard: Failed Impurities/Degradation Specifications: out of specification result for Clonazepam Related Compound (RC) A (a known impurity) at 15 month timepoint.
August 31, 2016DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Amlodipine Besylate Tablets, USP, 10 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-45
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
August 31, 2016DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Amlodipine Besylate Tablets, USP, 5 mg*, packaged in a) 100-count (10 x 10) unit dose blisters per carton, NDC 51079-451
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
August 31, 2016DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Amlodipine Besylate Tablets, USP, 2.5 mg*, packaged in a)100-count (10 x 10) unit dose blisters per carton, NDC 51079-45
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
February 10, 2016DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV,
Hazard: Failed Impurities/Degradation Specifications: out of specification result for known impurity at 6 month timepoint.
November 25, 2015DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufac
Hazard: Failed Impurities/Degradation Specifications: Out of specification for impurities.
May 27, 2015DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons,
Hazard: Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing
January 28, 2015DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only, Manufact
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
January 28, 2015DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls CIPROFLOXACIN TABLETS, USP, 500 mg, 100 Tablets (10 tablets per blister card. 10 blister cards per carton), Manufactured
Hazard: CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices
July 23, 2014DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only
Hazard: Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
March 19, 2014DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Man
Hazard: Failed Impurity/degradation Specification
May 29, 2013DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Budesonide Capsules, 3 mg, Enteric Coated, packaged in 30-count capsules unit dose (3 x 10 capsules blister packaged) pe
Hazard: Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.
February 27, 2013DrugsFDA
Mylan Institutional, Inc. (d.b.a. UDL Laboratories) recalls Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 bl
Hazard: Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.