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Fougera Pharmaceuticals Inc.

Fougera Pharmaceuticals Inc. Recalls

All product recalls associated with Fougera 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 2741–2760 of 4747 recalls

Desonide Ointment (Fougera) - Labeling Mix-up (2017)

Labeling: Label Mixup; Unit boxes labeled as Desonide Ointment 0.05% may contain tubes of Desonide Ointment labeled as Ketoconazole Cream

Class IIModerate

FDAMar 2, 2017Nationwide• Fougera Pharmaceuticals Inc.

Edex (Endo Pharmaceuticals) – sterility concern (2017)

Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks

Class IIModerate

FDAFeb 22, 2017Nationwide• Endo Pharmaceuticals, Inc.

A+D Diaper Rash Cream (Bayer) – labeling claim issue (2017)

Undeclared Allergen

Labeling: Incorrect/Undeclared Excipients: Firm is recalling A+D Diaper Rash Cream due to a labeling claim issue.

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Class IIILow

FDAFeb 21, 2017PR• Bayer HealthCare Pharmaceuticals, Inc.

Risedronate Sodium Tablets (Teva) – Dissolution Specification Failure (2017)

Failed Dissolution Specifications: low out of specification dissolution results found during stability testing.

Class IIILow

FDAFeb 17, 2017Nationwide• Teva Pharmaceuticals USA

Sato Clear Eye Drops (Sato Pharmaceutical) – Sterility Concern (2017)

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

Class IIModerate

FDAFeb 16, 2017HI• Sato Pharmaceutical Inc.

Dorama-Neo Eye Wash (Sato Pharmaceutical) – Sterility Concern (2017)

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

Class IIModerate

FDAFeb 16, 2017HI• Sato Pharmaceutical Inc.

Optic Splash Eye Drops (Sato Pharmaceutical) – Sterility Concern (2017)

Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

Class IIModerate

FDAFeb 16, 2017HI• Sato Pharmaceutical Inc.

Ibuprofen Lysine Injection (X-Gen) – Particulate Matter (2017)

Presence of Particulate Matter

Class IHigh

FDAFeb 8, 2017Nationwide• X-Gen Pharmaceuticals Inc.

Buprenorphine Naloxone Tablets (Teva) – Impurity Concerns (2017)

Failed Impurities/Degradation Specifications

Class IIModerate

FDAFeb 7, 2017Nationwide• Teva Pharmaceuticals USA