thejoe Duloxetine Hydrochloride

Duloxetine Hydrochloride recalls: 26 FDA reports

Recalls involving Duloxetine Hydrochloride. What was wrong with each batch, and how the FDA graded the risk.

26Reports

0Class I

21Ongoing

2026-06-17Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	24
Class III	2

By year reported

Year	Reports
2015	1
2016	1
2024	6
2025	15
2026	3

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsule

D-0583-2026 · Class II · reported 2026-06-17 · Ongoing

Why it was recalled: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product: 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. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Where it went: Nationwide within the United States
How much: 359,676 bottles

Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmace

D-0582-2026 · Class II · reported 2026-06-17 · Ongoing

Why it was recalled: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product: Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
Where it went: Nationwide within the United States
How much: 14,729 bottles.

Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S

D-0522-2026 · Class II · reported 2026-05-13 · Ongoing

Why it was recalled: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Product: Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Martorelles, (Barcelona), Spain, Dist. by. Breckenridge Pharmaceutical, Inc., Berkely Heights, NJ 07922, NDC 51991-748-90.
Where it went: Nationwide in the USA
How much: 165,761 90-count bottles

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmace

D-0216-2026 · Class II · reported 2025-12-10 · Ongoing

Why it was recalled: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Product: Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Where it went: Nationwide within the United States
How much: 7389 bottles

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmace

D-0215-2026 · Class II · reported 2025-12-10 · Ongoing

Why it was recalled: CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Product: Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
Where it went: Nationwide within the United States
How much: 3397 bottles

Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle

D-0100-2026 · Class II · reported 2025-11-05 · Ongoing

Why it was recalled: CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Product: 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.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
Where it went: U.S. Nationwide
How much: 172,263 bottles

Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pha

D-0621-2025 · Class II · reported 2025-09-17 · Ongoing

Why it was recalled: CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
Product: Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10
Where it went: AZ, IN, NJ
How much: 3,591 bottles

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pha

D-0580-2025 · Class II · reported 2025-08-20 · Ongoing

Why it was recalled: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Product: Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC 82009-032-10
Where it went: NJ, AZ, IN
How much: 1,856 bottles

Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Eur

D-0552-2025 · Class II · reported 2025-08-13 · Ongoing

Why it was recalled: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Product: Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
Where it went: U.S Nationwide
How much: 1,829 60-count bottles

Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Euro

D-0511-2025 · Class II · reported 2025-07-16 · Ongoing

Why it was recalled: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product: Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-750-33.
Where it went: U.S. Nationwide
How much: 12,242 30-count bottles

Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutic

D-0387-2025 · Class II · reported 2025-04-30 · Ongoing

Why it was recalled: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Product: Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L., Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922, NDC# 51991-748-10
Where it went: US Nationwide.
How much: 16,473 bottles

Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottl

D-0388-2025 · Class II · reported 2025-04-30 · Ongoing

Why it was recalled: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Product: 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 Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922
Where it went: US Nationwide.
How much: 343,344 bottles

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pha

D-0308-2025 · Class II · reported 2025-04-09 · Ongoing

Why it was recalled: CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.
Product: Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.
Where it went: Nationwide in the US
How much: 14,863 bottles

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europ

D-0271-2025 · Class II · reported 2025-03-19 · Ongoing

Why it was recalled: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Product: Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05
Where it went: Nationwide
How much: 11,125 bottles.

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Euro

D-0270-2025 · Class II · reported 2025-03-19 · Ongoing

Why it was recalled: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Product: Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
Where it went: Nationwide
How much: 14,749 bottles.

Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Euro

D-0269-2025 · Class II · reported 2025-03-19 · Ongoing

Why it was recalled: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Product: Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10
Where it went: Nationwide
How much: 11,100 bottles.

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pha

D-0161-2025 · Class II · reported 2025-01-01 · Ongoing

Why it was recalled: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Product: 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: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Where it went: Nationwide in the US
How much: 163,883 bottles

Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Ph

D-0162-2025 · Class II · reported 2025-01-01 · Ongoing

Why it was recalled: CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
Product: 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: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Where it went: Nationwide in the US
How much: 76,968 bottles

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europ

D-0009-2025 · Class II · reported 2024-10-23 · Completed

Why it was recalled: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product: 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.
Where it went: Product was distributed nationwide within the United States
How much: 7,107 bottles

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsu

D-0568-2024 · Class II · reported 2024-07-03 · Terminated

Why it was recalled: CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the proposed interim limit.
Product: Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottles, NDC 60429-165-90, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Packaged by GSMS, Incorporated, Camarillo, CA 93012.
Where it went: Nationwide in the U.S.
How much: 21,655 (30 count bottle), 34,149 (90 count bottle)

Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe

D-0562-2024 · Class II · reported 2024-06-26 · Terminated

Why it was recalled: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product: Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-90
Where it went: Nationwide in the USA
How much: 165,678, 90-count bottles

Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europ

D-0484-2024 · Class II · reported 2024-05-15 · Ongoing

Why it was recalled: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product: Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.
Where it went: US Nationwide.
How much: 281,554/90 count bottles

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-cou

D-0482-2024 · Class II · reported 2024-05-15 · Ongoing

Why it was recalled: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product: Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
Where it went: US Nationwide.
How much: 281,554/90 & 1000 count bottles

Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Eu

D-0483-2024 · Class II · reported 2024-05-15 · Ongoing

Why it was recalled: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product: Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.
Where it went: US Nationwide.
How much: 7,188/ 500 count bottles

DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios de

D-1255-2016 · Class III · reported 2016-07-20 · Terminated

Why it was recalled: 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
Product: DULOXETINE Delayed-Release Capsules, USP, 60 mg, 1000 count bottles, Rx only, Manufactured by: Laboratorios del Dr. Esteve, SA, Martorelles, Barcelona --- NDC 60429-166-10
Where it went: Nationwide. No foreign distribution.
How much: 2077 bottles

Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr.

D-0181-2016 · Class III · reported 2015-11-18 · Terminated

Why it was recalled: Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle
Product: Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10
Where it went: Nationwide
How much: 595 Bottles

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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