FDA drug recalls · openFDA
Is DULOXETINE HYDROCHLORIDE recalled?
The FDA has recorded 24 recalls of DULOXETINE HYDROCHLORIDE (2024–2026) , recalled under brand like DULOXETINE. 22 still ongoing.
0
Class I (most serious)
24
Class II
0
Class III
22
ongoing
A recall doesn't mean your pills are affected
Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of DULOXETINE HYDROCHLORIDE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit 8
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. 4
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit 3
CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit. 2
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. 2
The recalls
Class I and ongoing recalls first. Tap a recall for its full record and lot detail.
Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (NDC 51991-748-90); b) 1000 Capsules (51991-7 Class II ongoing
Breckenridge Pharmaceutical, Inc. 2026-06-04 lots: Lot: a) 241074C, Exp. Date May 2027; 240317, 240318, 240315C, 240373C, 240370C, 240375C, 240413C, Exp. Date February 2027; 240316,Exp. Date January 2027; 232311, Exp. Date November 2026; b) 240978C, 241052C, Exp. Date April 2027.
Duloxetine Delayed-Release Capsules USP, 60mg, Rx Only, 90-count bottle, Mfr. by Towa Pharmaceutical Eurpoe S.L., Marto Class II ongoing
Breckenridge Pharmaceutical, Inc. 2026-04-21 lots: Lot: 241069C, Exp 05/31/2027
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Eur Class II ongoing
Breckenridge Pharmaceutical, Inc. 2026-06-04 lots: Lot: 241180C, Exp. Date April 2027.
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Class II ongoing
Breckenridge Pharmaceutical, Inc. 2025-07-15 lots: Lot: 230836C, Exp.: 02/28/2026
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Eu Class II ongoing
Breckenridge Pharmaceutical, Inc. 2025-11-24 lots: Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
Duloxetine Delayed-Release Capsules USP, 60 mg, 1000-count bottles, Rx Only, Manufactured by Towa Pharmaceutical Europe, Class II ongoing
Breckenridge Pharmaceutical, Inc 2025-04-14 lots: Lot # 240987C, exp. date 04/2027 241014C, exp. date 04/2027
Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51 Class II ongoing
Breckenridge Pharmaceutical, Inc 2025-04-14 lots: Lot # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutica Class II ongoing
Breckenridge Pharmaceutical, Inc. 2025-07-25 lots: Lot 240539C, Exp 1/31/2027
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Eu Class II ongoing
Breckenridge Pharmaceutical, Inc. 2025-11-24 lots: Lot #: 240947C, 240962C, Exp. Date 04/2027
Duloxetine Delayed-Release Capsules, USP, 40mg, 30-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. M Class II ongoing
Breckenridge Pharmaceutical, Inc. 2025-06-30 lots: Lot # 230199, Exp. Date 01/31/2026
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Ma Class II ongoing
Breckenridge Pharmaceutical, Inc. 2025-02-28 lots: Lot#: 240098C, Expiration: 01/2027.
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. M Class II ongoing
Breckenridge Pharmaceutical, Inc. 2025-02-28 lots: Lot#: 240225C, Expiration: 01/2027
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutica Class II ongoing
Breckenridge Pharmaceutical, Inc. 2025-03-26 lots: Lot 240909C, Exp Date 03/31/2027
Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. M Class II ongoing
Breckenridge Pharmaceutical, Inc. 2025-02-28 lots: Lot#: 240301C, Expiration: 01/2027.
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutica Class II ongoing
Breckenridge Pharmaceutical, Inc. 2025-08-08 lots: Lot 240927C, Exp 04/30/2027
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 519 Class II ongoing
Breckenridge Pharmaceutical, Inc. 2025-10-09 lots: 90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutica Class II ongoing
Breckenridge Pharmaceutical, Inc 2024-12-06 lots: Lot # 222205C, exp. date 11/2025
Duloxetine Delayed-Release Capsules, USP, 60mg, 90-count bottle, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Mar Class II Terminated
Breckenridge Pharmaceutical, Inc 2024-05-17 lots: Lot #: 230035C, Exp. date 11/30/2025; 230101C, Exp. date 12/31/2025
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Di Class II Completed
Breckenridge Pharmaceutical, Inc 2024-10-10 lots: Lot #: 220128, Exp. Date 12/2024
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Ma Class II ongoing
Breckenridge Pharmaceutical, Inc 2024-04-29 lots: 230028C: Exp. Nov 2025 230106C: Exp. Dec 2025 230170C: Exp. Dec 2025 220039: Exp. Dec 2024 220363: Exp. Feb 2025
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles Class II ongoing
Breckenridge Pharmaceutical, Inc 2024-04-29 lots: 220265: Exp. Feb 2025 220088: Exp. Nov 2024 220267: Exp. Feb 2025 220256: Exp. Feb 2025 220225: Exp. Jan 2025 220269: Exp. Feb 2025
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Class II ongoing
Breckenridge Pharmaceutical, Inc 2024-04-29 lots: 220456: Exp. Feb 2025
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx Only, 90-count bottles (NDC 51991-748-90) Mfr. by: Towa Pharmaceutic Class II ongoing
Breckenridge Pharmaceutical, Inc 2024-12-06 lots: Lot # 230077C, exp. date 11/2025
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, a) 30 capsules bottles, NDC 60429-165-30; b) 90 capsules bottle Class II Terminated
Golden State Medical Supply Inc. 2024-05-13 lots: Lot: a) GS045371, Exp: 01/31/2025; b) GS045910, Exp. 01/31/2025
RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.