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Boehringer Ingelheim Pharmaceuticals, Inc.

Boehringer Ingelheim Pharmaceuticals, Inc. Recalls

All product recalls associated with Boehringer Ingelheim Pharmaceuticals, Inc..

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Recall Summary

Total Recalls

1000

Past Year

303

Class I (Serious)

Most Recent

Nov 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 2181–2200 of 4747 recalls

Mirapex Tablets (Boehringer) – Weight Specification Failure (2019)

Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.

Class IIILow

FDAMar 7, 2019Nationwide• Boehringer Ingelheim Pharmaceuticals, Inc.

Valsartan 40mg Tablets (Rising) – CGMP Impurity (2019)

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Class IIModerate

FDAMar 7, 2019Nationwide• Rising Pharmaceuticals, Inc.

Valsartan 80mg Tablets (Rising) – CGMP Impurity (2019)

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

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Class IIModerate

FDAMar 7, 2019Nationwide• Rising Pharmaceuticals, Inc.

Valsartan 320mg Tablets (Rising) – CGMP Impurity (2019)

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Class IIModerate

FDAMar 7, 2019Nationwide• Rising Pharmaceuticals, Inc.

Losartan Potassium Tablets (Preferred) – CGMP Impurity (2019)

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.

Class IIModerate

FDAMar 6, 2019CA, GA, IN• Preferred Pharmaceuticals, Inc

Stampede Utility Vehicles (Arctic Cat) – crash hazard (2019)

This recall involves all model year 2018 Stampede and Rustler model side by side Arctic Cat off-highway vehicles with VIN number 9003240 through 9004062. The recalled vehicles were sold in multiple colors, have four wheels and side-by-side seating for two or four people. The Stampede models have Textron Off Road on each side of the hood area and Stampede on each side of the box. The Rustler models have Rustler 850 on each side of the hood area and 4X4 on each side of the box. The Vin number is located under the front hood on all models.

CPSCMar 5, 2019Nationwide• Arctic Cat Inc., of Thief River Falls, Minn., a subsidiary of Textron Specialized Vehicles, of Augusta, Ga

Havoc Utility Vehicles (Arctic Cat) – fuel leak risk (2019)

Fire/Burn Risk

This recall involves Model Year 2019 Textron Havoc off-highway utility vehicles manufactured by Arctic Cat. The two-seat vehicles come in three color combinations: Charcoal metallic/black, red/black or white/black. The vehicles have Textron Off Road printed on each side of the hood and Havoc on each side of the rear cargo box. Vehicle identification numbers (VIN) ending in 9007497 through 9007717 are included in this recall. The VIN is stamped under the vehicle's front hood.

CPSCMar 5, 2019Nationwide• Arctic Cat Inc., of Thief River Falls, Minn., a subsidiary of Textron Specialized Vehicles, of Augusta, Ga.

Losartan Potassium Tablets (Legacy) – Impurity Risk (2019)

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Class IIModerate

FDAMar 1, 2019AR, CA, GA +2 more• Legacy Pharmaceutical Packaging LLC

Losartan Potassium Tablets (Legacy) – Impurity Risk (2019)

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Class IIModerate

FDAMar 1, 2019AR, CA, GA +2 more• Legacy Pharmaceutical Packaging LLC

Losartan Potassium Tablets (Legacy) – Impurity Risk (2019)

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Class IIModerate

FDAMar 1, 2019AR, CA, GA +2 more• Legacy Pharmaceutical Packaging LLC

Losartan Potassium Tablets (Legacy) – Impurity Risk (2019)

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected.

Class IIModerate

FDAMar 1, 2019AZ, IN, TN• Legacy Pharmaceutical Packaging LLC

Losartan Potassium Tablets (Camber) – Impurity Detection (2019)

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Class IIModerate

FDAFeb 28, 2019Nationwide• Camber Pharmaceuticals Inc

Losartan Potassium Tablets (Camber) – Impurity Detection (2019)

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Class IIModerate

FDAFeb 28, 2019Nationwide• Camber Pharmaceuticals Inc

Bupropion Extended-Release Tablets (Jubilant) – Dissolution Failure (2019)

Failed Dissolution Specifications; 9-monthstability timepoint

Class IIILow

FDAFeb 28, 2019Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Losartan Potassium Tablets (Camber) – Impurity Detection (2019)

CGMP Deviations; trace amounts of N-Nitroso N-Methyl 4-amino butyric acid (NMBA) detected in the active pharmaceutical ingredient

Class IIModerate

FDAFeb 28, 2019Nationwide• Camber Pharmaceuticals Inc

Moxifloxacin Ophthalmic Solution (Lupin) – Impurity Specifications (2019)

Failed Impurities/Degradation Specifications: Expansion of July 2018 and February 2019 recall due to high out-of-specification for impurities.

Class IIILow

FDAFeb 26, 2019Nationwide• Lupin Pharmaceuticals Inc.

Temozolomide Capsules (Amerigen) – Failed Dissolution (2019)

Failed dissolution specifications

Class IIILow

FDAFeb 19, 2019Nationwide• Amerigen Pharmaceuticals Inc.

Etomidate Injection (Heritage) – Subpotent Drug (2019)

Subpotent Drug.

Class IIModerate

FDAFeb 15, 2019Nationwide• Heritage Pharmaceuticals, Inc.

Diltiazem Capsules (Mylan) – Impurity Specification (2019)

Failed Impurities/Degradation Specifications: High out of specification results obtained during routine stability testing

Class IIILow

FDAFeb 13, 2019Nationwide• Mylan Pharmaceuticals Inc.

Lovastatin Tablets (Lupin) – CGMP Deviations (2019)

CGMP Deviations: Finished product made with lovastatin drug substance that was out of specification for individual impurity results.

Class IIILow

FDAFeb 13, 2019Nationwide• Lupin Pharmaceuticals Inc.