Breckenridge Pharmaceutical, Inc. FDA Recalls

30 recalls on file across drugs, 0 of them Class I and 21 still open. This firm is not matched to a listed company.

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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

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Product	Reason	Class	Initiated
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical EurClass IIJun 4, 2026CGMP Deviations: Presence of N-nitroso-duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Class IIDrugs	Jun 4, 2026
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-7Class IIJun 4, 2026CGMP Deviations: Presence of N-nitroso-duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Class IIDrugs	Jun 4, 2026
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., MartoClass IIApr 21, 2026CGMP Deviations; presence of N-nitroso-duloxetine impurity a	CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit	Class IIDrugs	Apr 21, 2026
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals EuClass IINov 24, 2025CGMP Deviations; presence of N-nitroso-duloxetine impurity a	CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit	Class IIDrugs	Nov 24, 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals EuClass IINov 24, 2025CGMP Deviations; presence of N-nitroso-duloxetine impurity a	CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit	Class IIDrugs	Nov 24, 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 519Class IIOct 9, 2025CGMP Deviations: N-nitroso-duloxetine impurity above the saf	CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.	Class IIDrugs	Oct 9, 2025
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa PharmaceuticaClass IIAug 8, 2025CGMP deviations: N-nitroso-duloxetine impurity above the pro	CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.	Class IIDrugs	Aug 8, 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa PharmaceuticaClass IIJul 25, 2025CGMP Deviations: Presence of N-nitroso-duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.	Class IIDrugs	Jul 25, 2025
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Class IIJul 15, 2025CGMP Deviations: Presence of N-nitroso-duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit	Class IIDrugs	Jul 15, 2025
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. MClass IIJun 30, 2025CGMP Deviations: Presence of N-nitroso-duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Class IIDrugs	Jun 30, 2025
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51Class IIApr 14, 2025CGMP Deviations: Presence of Nitrosamine Drug Substance Rela	CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.	Class IIDrugs	Apr 14, 2025
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe,Class IIApr 14, 2025CGMP Deviations: Presence of Nitrosamine Drug Substance Rela	CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.	Class IIDrugs	Apr 14, 2025
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa PharmaceuticaClass IIMar 26, 2025CGMP Deviations: presence of Nitrosamine Drug Substance Rela	CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above	Class IIDrugs	Mar 26, 2025
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. MaClass IIFeb 28, 2025CGMP Deviations: Presence of N-nitroso-duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.	Class IIDrugs	Feb 28, 2025
Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. MClass IIFeb 28, 2025CGMP Deviations: Presence of N-nitroso-duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.	Class IIDrugs	Feb 28, 2025
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. MClass IIFeb 28, 2025CGMP Deviations: Presence of N-nitroso-duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.	Class IIDrugs	Feb 28, 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa PharmaceuticClass IIDec 6, 2024CGMP Deviations: presence of N-nitroso-duloxetine impurity a	CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.	Class IIDrugs	Dec 6, 2024
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa PharmaceuticaClass IIDec 6, 2024CGMP Deviations: presence of N-nitroso-duloxetine impurity a	CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.	Class IIDrugs	Dec 6, 2024
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. DiClass IIOct 10, 2024CGMP Deviations: Presence of N-nitroso-duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Class IIDrugs	Oct 10, 2024
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. MarClass IIMay 17, 2024CGMP Deviations: Presence of N-nitroso-duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Class IIDrugs	May 17, 2024
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottlesClass IIApr 29, 2024CGMP Deviations: Presence of N-nitroso-duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Class IIDrugs	Apr 29, 2024
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.Class IIApr 29, 2024CGMP Deviations: Presence of N-nitroso-duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Class IIDrugs	Apr 29, 2024
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. MaClass IIApr 29, 2024CGMP Deviations: Presence of N-nitroso-duloxetine impurity a	CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit	Class IIDrugs	Apr 29, 2024
Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991Class IIMar 2, 2023CGMP Deviations: Potential risk of Cross Contamination	CGMP Deviations: Potential risk of Cross Contamination	Class IIDrugs	Mar 2, 2023
Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA,Class IIMar 2, 2023CGMP Deviations: Potential risk of Cross Contamination	CGMP Deviations: Potential risk of Cross Contamination	Class IIDrugs	Mar 2, 2023
Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1Class IIMar 2, 2023CGMP Deviations: Potential risk of Cross Contamination	CGMP Deviations: Potential risk of Cross Contamination	Class IIDrugs	Mar 2, 2023
Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 5199Class IIMar 2, 2023CGMP Deviations: Potential risk of Cross Contamination	CGMP Deviations: Potential risk of Cross Contamination	Class IIDrugs	Mar 2, 2023
Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 519Class IIMar 2, 2023CGMP Deviations: Potential risk of Cross Contamination	CGMP Deviations: Potential risk of Cross Contamination	Class IIDrugs	Mar 2, 2023
Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA,Class IIMar 2, 2023CGMP Deviations: Potential risk of Cross Contamination	CGMP Deviations: Potential risk of Cross Contamination	Class IIDrugs	Mar 2, 2023
Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge PharmaceuticalClass IIMar 11, 2021Failed Impurities/Degradation Specifications: Out-of-Specifi	Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities dur	Class IIDrugs	Mar 11, 2021