PillDuloxetine Hydrochloride
Brands: Duloxetine Delayed-Release · Duloxetine · Duloxetine Hydrochloride
12 active makers
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US acquisition costNADAC · per unit
Average across 13 priced NDCs. A benchmark of pharmacy acquisition cost — not a retail quote.
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
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 | unknown | 12 | SUPPLYING |
| Aphena Pharma Solutions - Tennessee, LLC | unknown | 11 | SUPPLYING |
| Preferred Pharmaceuticals Inc. | unknown | 6 | SUPPLYING |
| Golden State Medical Supply, Inc. | unknown | 6 | SUPPLYING |
| Yaopharma Co., Ltd. | unknown | 5 | SUPPLYING |
| A-S Medication Solutions | unknown | 4 | SUPPLYING |
| Quallent Pharmaceuticals Health LLC | unknown | 4 | SUPPLYING |
| NuCare Pharmaceuticals, Inc. | unknown | 1 | SUPPLYING |
| BluePoint Laboratories | unknown | 1 | SUPPLYING |
| REMEDYREPACK INC. | repackager | 1 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- Jun 4, 2026RECALLRecall (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, 2026RECALLRecall (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, 2026RECALLRecall (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, 2025RECALLRecall (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, 2025RECALLRecall (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, 2025RECALLRecall (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, 2025RECALLRecall (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, 2025RECALLRecall (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, 2025RECALLRecall (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, 2025RECALLRecall (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, 2025RECALLRecall (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, 2025RECALLRecall (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, 2025RECALLRecall (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, 2025RECALLRecall (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, 2025RECALLRecall (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, 2025RECALLRecall (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, 2024RECALLRecall (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, 2024RECALLRecall (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, 2024RECALLRecall (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, 2024RECALLRecall (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, 2024RECALLRecall (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, 2024RECALLRecall (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.
- Apr 29, 2024RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottle…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit — Recalling firm: Breckenridge Pharmaceutical, Inc — US Nationwide.
- Apr 29, 2024RECALLRecall (Class II): Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, 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 — US Nationwide.
- Jun 28, 2016RECALLRecall (Class III): DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Est…
Labeling; Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on container label is 02/2019, correct expiration date should be 02/2018 — Recalling firm: Golden State Medical Supply Inc. — Nationwide. No foreign distribution.