--- title: "Breckenridge Pharmaceutical, Inc Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Breckenridge Pharmaceutical, Inc recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/breckenridge-pharmaceutical-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Breckenridge Pharmaceutical, Inc recall records **21** reported ongoing 29 records in this archive. Latest source date Jun 4, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Jun 4, 2026 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by...](https://isitonrecall.com/recall/fda-drug-d-0582-2026-duloxetine-delayed-release-capsules-usp-30mg-1000-capsule-bottles-rx-only-manufactured-by-towa-pharm/) CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0582-2026%22) Jun 4, 2026 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-748-10), Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L...](https://isitonrecall.com/recall/fda-drug-d-0583-2026-duloxetine-delayed-release-capsules-usp-60mg-packaged-in-a-90-capsules-ndc-51991-748-90-b-1000-capsu/) CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b)...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0583-2026%22) Apr 21, 2026 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmac...](https://isitonrecall.com/recall/fda-drug-d-0522-2026-duloxetine-delayed-release-capsules-usp-60mg-rx-only-90-count-bottle-mfr-by-towa-pharmaceutical-eurp/) CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Class II Reported ongoing Distribution: Nationwide in the USA [Official source for Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceuti...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0522-2026%22) Nov 24, 2025 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured ...](https://isitonrecall.com/recall/fda-drug-d-0215-2026-duloxetine-delayed-release-capsules-usp-60-mg-1000-capsule-bottles-rx-only-manufactured-by-towa-phar/) CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0215-2026%22) Nov 24, 2025 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed b...](https://isitonrecall.com/recall/fda-drug-d-0216-2026-duloxetine-delayed-release-capsules-usp-60-mg-1000-capsule-bottles-rx-only-manufactured-by-towa-phar/) CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit Class II Reported ongoing Distribution: Nationwide within the United States [Official source for Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0216-2026%22) Oct 9, 2025 FDA drug enforcement ### [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, Mfr. by: Towa Pharmaceutical Europe, S...](https://isitonrecall.com/recall/fda-drug-d-0100-2026-duloxetine-delayed-release-capsules-usp-60-mg-a-90-count-bottle-ndc-51991-748-90-b-1000-count-bottle/) CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0100-2026%22) Aug 8, 2025 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufact...](https://isitonrecall.com/recall/fda-drug-d-0621-2025-duloxetine-delayed-release-capsules-usp-30-mg-1-000-capsules-per-bottle-rx-only-manufactured-by-towa/) CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. Class II Reported ongoing Distribution: AZ, IN, NJ [Official source for Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0621-2025%22) Jul 25, 2025 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufact...](https://isitonrecall.com/recall/fda-drug-d-0580-2025-duloxetine-delayed-release-capsules-usp-60-mg-1-000-capsules-per-bottle-rx-only-manufactured-by-towa/) CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class II Reported ongoing Distribution: NJ, AZ, IN [Official source for Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0580-2025%22) Jul 15, 2025 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenr...](https://isitonrecall.com/recall/fda-drug-d-0552-2025-duloxetine-delayed-release-capsules-usp-60mg-1-000-count-bottles-rx-only-mfr-by-towa-pharmaceutical/) CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit Class II Reported ongoing Distribution: U.S Nationwide [Official source for Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharm...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0552-2025%22) Jun 30, 2025 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Phar...](https://isitonrecall.com/recall/fda-drug-d-0511-2025-duloxetine-delayed-release-capsules-usp-40mg-30-count-bottles-rx-only-mfr-by-towa-pharmaceutical-eur/) CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Reported ongoing Distribution: U.S. Nationwide [Official source for Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmace...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0511-2025%22) Apr 14, 2025 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. B...](https://isitonrecall.com/recall/fda-drug-d-0387-2025-duloxetine-delayed-release-capsules-usp-60-mg-1000-count-bottles-rx-only-manufactured-by-towa-pharma/) CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. Class II Reported ongoing Distribution: US Nationwide. [Official source for Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0387-2025%22) Apr 14, 2025 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical...](https://isitonrecall.com/recall/fda-drug-d-0388-2025-duloxetine-delayed-release-capsules-usp-30-mg-a-90-count-bottles-ndc-51991-747-90-b-1000-count-bottl/) CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. Class II Reported ongoing Distribution: US Nationwide. [Official source for Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 100...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0388-2025%22) Mar 26, 2025 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distribu...](https://isitonrecall.com/recall/fda-drug-d-0308-2025-duloxetine-delayed-release-capsules-usp-30-mg-rx-only-1-000-capsules-per-bottle-manufactured-by-towa/) CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit. Class II Reported ongoing Distribution: Nationwide in the US [Official source for Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0308-2025%22) Feb 28, 2025 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Ph...](https://isitonrecall.com/recall/fda-drug-d-0269-2025-duloxetine-delayed-release-capsules-usp-60mg-rx-only-1000-count-bottles-mfr-by-towa-pharmaceutical-e/) CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class II Reported ongoing Distribution: Nationwide [Official source for Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharma...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0269-2025%22) Feb 28, 2025 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Ph...](https://isitonrecall.com/recall/fda-drug-d-0270-2025-duloxetine-delayed-release-capsules-usp-30mg-rx-only-1000-count-bottles-mfr-by-towa-pharmaceutical-e/) CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class II Reported ongoing Distribution: Nationwide [Official source for Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharma...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0270-2025%22) Feb 28, 2025 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pha...](https://isitonrecall.com/recall/fda-drug-d-0271-2025-duloxetine-delayed-release-capsules-usp-20mg-rx-only-500-count-bottles-mfr-by-towa-pharmaceutical-eu/) CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class II Reported ongoing Distribution: Nationwide [Official source for Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmac...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0271-2025%22) Dec 6, 2024 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by:...](https://isitonrecall.com/recall/fda-drug-d-0161-2025-duloxetine-delayed-release-capsules-usp-30mg-rx-only-90-count-bottles-ndc-51991-747-90-mfr-by-towa-p/) CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class II Reported ongoing Distribution: Nationwide in the US [Official source for Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr....](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0161-2025%22) Dec 6, 2024 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by...](https://isitonrecall.com/recall/fda-drug-d-0162-2025-duloxetine-delayed-release-capsules-usp-60-mg-rx-only-90-count-bottles-ndc-51991-748-90-mfr-by-towa/) CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. Class II Reported ongoing Distribution: Nationwide in the US [Official source for Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0162-2025%22) Oct 10, 2024 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Distributed by: BPI, NDC 51991-746-05.](https://isitonrecall.com/recall/fda-drug-d-0009-2025-duloxetine-delayed-release-capsules-usp-20mg-rx-only-500-count-bottles-mfr-by-towa-pharmaceutical-eu/) CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Reported completed Distribution: Product was distributed nationwide within the United States [Official source for Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmac...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0009-2025%22) May 17, 2024 FDA drug enforcement ### [Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharm...](https://isitonrecall.com/recall/fda-drug-d-0562-2024-duloxetine-delayed-release-capsules-usp-60mg-90-count-bottle-rx-only-mfr-by-towa-pharmaceutical-euro/) CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit Class II Reported terminated Distribution: Nationwide in the USA [Official source for Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceu...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0562-2024%22) ## Reasons in these listed records - CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit - CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit - CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. - CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. These examples come from this result page and are not a ranking of every recall reason. ## Checking Breckenridge Pharmaceutical, Inc ### Is there a recall on breckenridge pharmaceutical, inc right now? This archive contains 29 records, including 21 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Breckenridge Pharmaceutical, Inc](https://isitonrecall.com/check/?q=Breckenridge%20Pharmaceutical%2C%20Inc) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)