Duloxetine Hydrochloride - manufacturers, supply & price · Pillstats

Who makes it12 active · 0 exited

US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.

Labeler	Type	Packages	Status
Bryant Ranch Prepack	repackager	29	SUPPLYING
Breckenridge Pharmaceutical, Inc.	unknown	13	SUPPLYING
Proficient Rx LP	repackager	12	SUPPLYING
Aphena Pharma Solutions - Tennessee, LLC	repackager	11	SUPPLYING
Preferred Pharmaceuticals Inc.	repackager	6	SUPPLYING
Golden State Medical Supply, Inc.	repackager	6	SUPPLYING
Yaopharma Co., Ltd.	unknown	5	SUPPLYING
A-S Medication Solutions	repackager	4	SUPPLYING
Quallent Pharmaceuticals Health LLC	unknown	4	SUPPLYING
NuCare Pharmaceuticals,Inc.	repackager	1	SUPPLYING
BluePoint Laboratories	relabeler	1	SUPPLYING
REMEDYREPACK INC.	repackager	1	SUPPLYING

Regulatory & supply eventsFDA · US

Shortages, recalls, and registration changes attached to this drug concept.

Dec 31, 2027
EXITUS registration discontinued: duloxetine hydrochloride — Golden State Medical Supply, Inc. (NDC 51407-818)
Nov 30, 2027
EXITUS registration discontinued: duloxetine hydrochloride — Golden State Medical Supply, Inc. (NDC 51407-819)
Oct 31, 2027
EXITUS registration discontinued: duloxetine hydrochloride — Golden State Medical Supply, Inc. (NDC 51407-817)
Jun 4, 2026
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Eu…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit — Recalling firm: Breckenridge Pharmaceutical, Inc. — Nationwide within the United States
Jun 4, 2026
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit — Recalling firm: Breckenridge Pharmaceutical, Inc. — Nationwide within the United States
Apr 21, 2026
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Mart…
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit — Recalling firm: Breckenridge Pharmaceutical, Inc. — Nationwide in the USA
Nov 24, 2025
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals E…
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit — Recalling firm: Breckenridge Pharmaceutical, Inc. — Nationwide within the United States
Nov 24, 2025
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals E…
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit — Recalling firm: Breckenridge Pharmaceutical, Inc. — Nationwide within the United States
Oct 9, 2025
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51…
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm. — Recalling firm: Breckenridge Pharmaceutical, Inc. — U.S. Nationwide
Aug 8, 2025
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutic…
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. — Recalling firm: Breckenridge Pharmaceutical, Inc. — AZ, IN, NJ
Jul 25, 2025
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutic…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Recalling firm: Breckenridge Pharmaceutical, Inc. — NJ, AZ, IN
Jul 15, 2025
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit — Recalling firm: Breckenridge Pharmaceutical, Inc. — U.S Nationwide
Jun 30, 2025
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. …
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit — Recalling firm: Breckenridge Pharmaceutical, Inc. — U.S. Nationwide
Apr 14, 2025
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe…
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. — Recalling firm: Breckenridge Pharmaceutical, Inc — US Nationwide.
Apr 14, 2025
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 5…
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. — Recalling firm: Breckenridge Pharmaceutical, Inc — US Nationwide.
Mar 26, 2025
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutic…
CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit. — Recalling firm: Breckenridge Pharmaceutical, Inc. — Nationwide in the US
Feb 28, 2025
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. …
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Recalling firm: Breckenridge Pharmaceutical, Inc. — Nationwide
Feb 28, 2025
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. …
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Recalling firm: Breckenridge Pharmaceutical, Inc. — Nationwide
Feb 28, 2025
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. M…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Recalling firm: Breckenridge Pharmaceutical, Inc. — Nationwide
Dec 6, 2024
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutic…
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Recalling firm: Breckenridge Pharmaceutical, Inc — Nationwide in the US
Dec 6, 2024
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceuti…
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. — Recalling firm: Breckenridge Pharmaceutical, Inc — Nationwide in the US
Oct 10, 2024
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. D…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit — Recalling firm: Breckenridge Pharmaceutical, Inc — Product was distributed nationwide within the United States
May 17, 2024
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Ma…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit — Recalling firm: Breckenridge Pharmaceutical, Inc — Nationwide in the USA
May 13, 2024
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottl…
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit. — Recalling firm: Golden State Medical Supply Inc. — Nationwide in the U.S.
Apr 29, 2024
RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit — Recalling firm: Breckenridge Pharmaceutical, Inc — US Nationwide.

Duloxetine Hydrochloride

US acquisition costNADAC · per unit

Medicaid dispensing volumeSDUD · per quarter

Who makes it12 active · 0 exited

Regulatory & supply eventsFDA · US