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Sciegen Pharmaceuticals Inc

Sciegen Pharmaceuticals Inc Recalls

All product recalls associated with Sciegen 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 2261–2280 of 4747 recalls

Irbesartan Tablets (Sciegen) – NDEA Impurity (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDAOct 29, 2018Nationwide• Sciegen Pharmaceuticals Inc

Irbesartan Tablets 300mg (Westminster) – NDEA Trace Impurity (2018)

CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.

Class IIModerate

FDAOct 29, 2018Nationwide• Westminster Pharmaceuticals Llc

Irbesartan Tablets 150mg (Westminster) – NDEA Trace Impurity (2018)

CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.

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Class IIModerate

FDAOct 29, 2018Nationwide• Westminster Pharmaceuticals Llc

Irbesartan Tablets (Westminster) – NDEA Impurity (2018)

CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.

Class IIModerate

FDAOct 29, 2018Nationwide• Westminster Pharmaceuticals Llc

Irbesartan Tablets 300mg (Sciegen) – NDEA Impurity Detected (2018)

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

Class IIModerate

FDAOct 29, 2018Nationwide• Sciegen Pharmaceuticals Inc

Ortho-Novum 1/35 Tablets (Janssen) – Incorrect Dispenser Instructions (2018)

Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.

Class IIModerate

FDAOct 23, 2018Nationwide• Janssen Pharmaceuticals, Inc.

Ortho-Novum 7/7/7 Tablets (Janssen) – Incorrect Dispenser Instructions (2018)

Labeling: Incorrect Instructions; Instructions included for use with the Veridate dispenser contained instructions for the Dialpak dispenser.

Class IIModerate

FDAOct 23, 2018Nationwide• Janssen Pharmaceuticals, Inc.

Catapres .2 (Boehringer) – Dissolution Specification Failure (2018)

Failed Dissolution Specifications: OOS resultsduring routine stability testing

Class IIModerate

FDAOct 22, 2018Nationwide• Boehringer Ingelheim Pharmaceuticals, Inc.

Metoprolol Succinate Tablets (Teva) – Dissolution Test Failure (2018)

Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.

Class IIModerate

FDAOct 19, 2018Nationwide• Teva Pharmaceuticals USA

Children's Allergy Solution (Taro) – Impurity Limit Exceeded (2018)

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

Class IIModerate

FDAOct 19, 2018Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Children's Allergy Solution (Taro) – Impurity Limit Exceeded (2018)

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

Class IIModerate

FDAOct 19, 2018Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Children's 24 Hour Allergy (Taro Pharmaceuticals) – Impurity Specification (2018)

Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.

Class IIModerate

FDAOct 19, 2018Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Cidofovir Injection (Heritage Pharmaceuticals) – Sterility Concern (2018)

Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle

Class IIModerate

FDAOct 15, 2018Nationwide• Heritage Pharmaceuticals, Inc.

Testosterone Topical Solution (Lupin) – Defective Pump (2018)

Defective Container: Repetitive complaints received indicating pump not working.

Class IIILow

FDAOct 9, 2018Nationwide• Lupin Pharmaceuticals Inc.

Temozolomide Capsules (Amerigen) – Dissolution Specification Failure (2018)

Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.

Class IIILow

FDAOct 5, 2018Nationwide• Amerigen Pharmaceuticals Inc.

Contrave Tablets (Orexigen) – Packaging Defect (2018)

Container packaging defect.

Class IIILow

FDAOct 5, 2018Nationwide• Orexigen Therapeutics, Inc.

Amlodipine Besylate Tablets (InvaGen) – Subpotent Drug (2018)

Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.

Class IIILow

FDAOct 3, 2018Nationwide• InvaGen Pharmaceuticals, Inc.

Pantoprazole Tablets (Jubilant Cadista) – Tablet Discoloration (2018)

Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.

Class IIModerate

FDAOct 2, 2018Nationwide• Jubilant Cadista Pharmaceuticals, Inc.

Alprostadil Injection (Teva Pharmaceuticals) – Impurity Specification (2018)

Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtained during routine stability testing

Class IIModerate

FDASep 27, 2018Nationwide• Teva Pharmaceuticals USA

Clozapine Tablets (Teva Pharmaceuticals) – Disintegration Failure (2018)

Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.

Class IIModerate

FDASep 21, 2018Nationwide• Teva Pharmaceuticals USA