Breckenridge Pharmaceutical recalls
Breckenridge Pharmaceutical appears in 35 official U.S. recall notices indexed by RecallRadar, most recently on 2026-06-17.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 35 |
|---|---|
| Published | 2015-11-18 to 2026-06-17 |
| By agency | FDA Drug (35) |
| By classification | Class II (32), Class III (3) |
| By status | ongoing (21), terminated (13), completed (1) |
| Distribution named in notices | AZ, IN, NJ, US |
Recalls
- Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorell…
FDA Drug · Class II · 2026-06-17 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90)
FDA Drug · Class II · 2026-06-17 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona),…
FDA Drug · Class II · 2026-05-13 · Breckenridge Pharmaceutical
Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit - Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrel…
FDA Drug · Class II · 2025-12-10 · Breckenridge Pharmaceutical
Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit - Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrel…
FDA Drug · Class II · 2025-12-10 · Breckenridge Pharmaceutical
Reason: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit - Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only,…
FDA Drug · Class II · 2025-11-05 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. - Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Mar…
FDA Drug · Class II · 2025-09-17 · Breckenridge Pharmaceutical
Reason: CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. - Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Mar…
FDA Drug · Class II · 2025-08-20 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. - Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barce…
FDA Drug · Class II · 2025-08-13 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit - Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelon…
FDA Drug · Class II · 2025-07-16 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Onl…
FDA Drug · Class II · 2025-04-30 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. - Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed…
FDA Drug · Class II · 2025-04-30 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. - Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Mar…
FDA Drug · Class II · 2025-04-09 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit. - Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcel…
FDA Drug · Class II · 2025-03-19 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. - Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelo…
FDA Drug · Class II · 2025-03-19 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. - Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcel…
FDA Drug · Class II · 2025-03-19 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. - Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Mar…
FDA Drug · Class II · 2025-01-01 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. - Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Mart…
FDA Drug · Class II · 2025-01-01 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. - Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI,…
FDA Drug · Class II · 2024-10-23 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona…
FDA Drug · Class II · 2024-06-26 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barc…
FDA Drug · Class II · 2024-05-15 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelo…
FDA Drug · Class II · 2024-05-15 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10)…
FDA Drug · Class II · 2024-05-15 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c) 1,000-count bottle,…
FDA Drug · Class II · 2023-03-22 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Potential risk of Cross Contamination - Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,…
FDA Drug · Class II · 2023-03-22 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Potential risk of Cross Contamination - Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt
FDA Drug · Class II · 2023-03-22 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Potential risk of Cross Contamination - Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt
FDA Drug · Class II · 2023-03-22 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Potential risk of Cross Contamination - Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC 51991-0705-05) and c) 1…
FDA Drug · Class II · 2023-03-22 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Potential risk of Cross Contamination - Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC 51991-0707-05), Rx onl…
FDA Drug · Class II · 2023-03-22 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: Potential risk of Cross Contamination - Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT,…
FDA Drug · Class II · 2021-03-24 · Breckenridge Pharmaceutical
Reason: Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing. - Solifenacin Succinate Tablets, 10 mg, packaged in a) 30-count bottles (NDC 51991-894-33) and b) 90-count bottles (NDC 51991-894-90), Distri…
FDA Drug · Class II · 2020-03-25 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets. - Solifenacin Succinate Tablets, 5mg, packaged in a) 30-count bottles (NDC 51991-893-33) and b) 90-count bottles (NDC 51991-893-90) Distribut…
FDA Drug · Class II · 2020-03-25 · Breckenridge Pharmaceutical
Reason: CGMP Deviations: During manufacturing Solifenacin Succinate Tablets might convert to Solifenacin Tartrate Tablets. - Zoledronic Acid Injection 5 mg/100 mL (0.05 mg/mL), Solution for Intravenous Infusion, Sterile Solution, 100 mL Single - Dose Vial per Cart…
FDA Drug · Class III · 2020-03-04 · Breckenridge Pharmaceutical
Reason: Failed Impurities/Degradation Specifications: Out-of-specification results obtained for impurities during stability testing. - Megestrol Acetate Oral Suspension, USP 625 mg/5mL, 150 mL bottle, Rx only, Distributed by: Breckenridge Pharmaceutical, Inc
FDA Drug · Class III · 2018-11-21 · Breckenridge Pharmaceutical
Reason: Failed Stability Specifications: Out-of-Specification results obtained for particle size distribution during stability testing. - Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spa…
FDA Drug · Class III · 2015-11-18 · Breckenridge Pharmaceutical
Reason: Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle