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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

422

Class I (Serious)

54

Most Recent

Jan 2026

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 2161–2180 of 4598 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 (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 (Sciegen) – NDEA Impurity (2018)

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

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Class II

Moderate

FDAOct 29, 2018Nationwide• Sciegen Pharmaceuticals Inc

Omnipaque Injection (GE Healthcare) – Container Defect (2018)

Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.

Class IIModerate

FDAOct 29, 2018TN• GE Healthcare Inc. Life Sciences

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

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

Failed Dissolution Specifications: OOS resultsduring routine stability testing

Class IIModerate

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

Roasted Onion Base (Karlsburger) – potential contamination (2018)

Firm is recalling a Roasted Onion Base product due to potential Listeria monocytogenes and Salmonella contamination.

Class IIModerate

FDAOct 19, 2018MN• Karlsburger Foods, Inc.

Mind Body Soul Breakfast Blend (Equal Exchange) – Mislabeled Caffeine (2018)

Caffeinated coffee was packaged in decaffeinated packaging.

Class IIModerate

FDAOct 18, 2018AL, AK, DE +11 more• Equal Exchange Cooperative dba Equal Exchange, Inc.

Estradiol 15mg Pellet (Qualgen) – Sterility Risk (2018)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 17, 2018Nationwide• Qualgen, LLC

Estradiol 18mg Pellet (Qualgen) – Sterility Risk (2018)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 17, 2018Nationwide• Qualgen, LLC

Testosterone 37.5mg Pellet (Qualgen) – Sterility Risk (2018)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 17, 2018Nationwide• Qualgen, LLC

Testosterone 100mg Pellet (Qualgen) – Sterility Risk (2018)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 17, 2018Nationwide• Qualgen, LLC

Estradiol 10mg Pellet (Qualgen) – Sterility Risk (2018)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 17, 2018Nationwide• Qualgen, LLC

Testosterone 50mg Pellet (Qualgen) – Sterility Risk (2018)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 17, 2018Nationwide• Qualgen, LLC

Testosterone/Anastrozole Pellet (Qualgen) – Sterility Risk (2018)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 17, 2018Nationwide• Qualgen, LLC

Estradiol 6mg Pellet (Qualgen) – Sterility Risk (2018)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 17, 2018Nationwide• Qualgen, LLC

Testosterone 25mg Pellet (Qualgen) – Sterility Risk (2018)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 17, 2018Nationwide• Qualgen, LLC

Testosterone 200mg Pellet (Qualgen) – Sterility Risk (2018)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 17, 2018Nationwide• Qualgen, LLC

Testosterone 87.5mg Pellet (Qualgen) – Sterility Risk (2018)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 17, 2018Nationwide• Qualgen, LLC

Estradiol 25mg Pellet (Qualgen) – Sterility Risk (2018)

Lack of Assurance of Sterility

Class IIModerate

FDAOct 17, 2018Nationwide• Qualgen, LLC