Breckenridge Pharmaceutical recalls

Breckenridge Pharmaceutical has 35 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 17 Jun 2026. 21 are still ongoing. 6 were reported in the last 12 months. The most frequent reason is nitrosamine impurity.

Total recalls35since 2015

Last 12 months6reported

Class I00% of total

Ongoing21latest 17 Jun 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 2 0Feb 3 3 0May 0 1 2Aug 1 0 1Nov 2 0 0Feb 0 0 1May 2 0 0Aug 0 0

Severity split

Class I 0 0%Class II 32 91%Class III 3 9%

Why breckenridge pharmaceutical is recalled

Product types

By year

202639%
20251543%
2024514%
2023617%
202113%
202039%
201813%
201513%

Ongoing breckenridge pharmaceutical recalls

21 active

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
17 Jun 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
10 Dec 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
10 Dec 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
5 Nov 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) bottle recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide

All breckenridge pharmaceutical recalls, newest first

35 total

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
17 Jun 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
13 May 2026Drug	CLASS II	Duloxetine Delayed-Release Capsules USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
10 Dec 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
10 Dec 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
5 Nov 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) bottle recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
17 Sep 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	AZ, IN, NJ
20 Aug 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	AZ, IN, NJ
13 Aug 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
16 Jul 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 40mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
30 Apr 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules USP, 30 mg, a.) bottles recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
30 Apr 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
9 Apr 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
19 Mar 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
19 Mar 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
19 Mar 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 20mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
1 Jan 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
1 Jan 2025Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
23 Oct 2024Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 20mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
26 Jun 2024Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
15 May 2024Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 20 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
15 May 2024Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 30mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
15 May 2024Drug	CLASS II	Duloxetine Delayed-Release Capsules, USP, 60 mg recalledDuloxetine	Breckenridge Pharmaceutical	Nitrosamine Impurity	Nationwide
22 Mar 2023Drug	CLASS II	Clobazam Tablets, 20 mg, CIV recalled by Breckenridge Pharmaceutical	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
22 Mar 2023Drug	CLASS II	Clobazam Tablets, 10 mg, CIV recalled by Breckenridge Pharmaceutical	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
22 Mar 2023Drug	CLASS II	Alprazolam Tablets, USP, 2 mg, CIV recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
22 Mar 2023Drug	CLASS II	Alprazolam Tablets, USP, 0.5mg, CIV recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
22 Mar 2023Drug	CLASS II	Alprazolam Tablets, USP, 0.25mg, CIV recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
22 Mar 2023Drug	CLASS II	Alprazolam Tablets, USP, 1 mg, CIV recalled	Breckenridge Pharmaceutical	Manufacturing (CGMP) Deviations	Nationwide
24 Mar 2021Drug	CLASS II	Omeprazole Delayed-Release Capsules, USP, 20 mg recalled	Breckenridge Pharmaceutical	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.