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

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

All product recalls associated with Mylan Institutional, Inc. (d.b.a. UDL Laboratories).

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

Mar 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 21–31 of 31 recalls

Meclizine Tablets (Mylan) – Impurity Specification (2015)

Failed Impurities/Degradation Specifications: Out of specification for impurities.

Class IIILow

FDANov 2, 2015Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Fexofenadine Tablets (Mylan) – Impurity Specification (2015)

Failed Impurities/Degradation Specifications: the manufacturer, recalled product due to slightly above specification results for a Related Compound during routine stability testing

Class IIILow

FDAMar 26, 2015Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Diltiazem HCl Extended-release Capsules (Mylan) – Impurity Specification Failure (2014)

Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.

Page 2 of 2Next

Class IIILow

FDAJul 3, 2014Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Carisoprodol Tablets (Mylan) – Impurity Specification Failure (2014)

Failed Impurity/degradation Specification

Class IIILow

FDAJan 28, 2014Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Ciprofloxacin Tablets (Mylan) – CGMP Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

Class IIModerate

FDASep 26, 2013Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Lamotrigine Tablets (Mylan) – CGMP Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

Class IIModerate

FDASep 26, 2013Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Amlodipine Tablets 10mg (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 17, 2013Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Amlodipine Tablets 5mg (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 17, 2013Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Amlodipine Tablets 2.5mg (Mylan) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.

Class IIModerate

FDASep 17, 2013Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Budesonide Capsules 3mg (Mylan) – dissolution failure (2013)

Failed Dissolution Specifications: Routine stability testing at the 12-month interval yielded an out-of-specification (OOS) result for dissolution testing.

Class IIILow

FDAMay 15, 2013Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Hydrocodone Acetaminophen Tablets (Mylan Institutional) – Superpotent Medication (2012)

Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components.

Class IHigh

FDADec 14, 2012Nationwide• Mylan Institutional, Inc. (d.b.a. UDL Laboratories)