FDA DrugsClass II
Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only, M...
Published: June 17, 2026Recall ID: D-0582-2026Category: drugsCountry: US
Reason for Recall / Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product Description & Identification
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
Additional Source Details
| Field | Value |
|---|---|
| City | Berkeley Heights |
| State | NJ |
| Openfda › Unii | 9044SC542W |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 596926 |
| Openfda › Rxcui › 2 | 596930 |
| Openfda › Rxcui › 3 | 596934 |
| Openfda › Rxcui › 4 | 616402 |
| Openfda › Spl id | 32327581-bdab-41ac-9adc-bf208e1c4e42 |
| Openfda › Brand name | DULOXETINE |
| Openfda › Spl set id | caef6f50-1571-4ec7-8f8c-42b924d323ee |
| Openfda › Package ndc › 1 | 51991-746-06 |
| Openfda › Package ndc › 2 | 51991-746-90 |
| Openfda › Package ndc › 3 | 51991-746-05 |
| Openfda › Package ndc › 4 | 51991-747-33 |
| Openfda › Package ndc › 5 | 51991-747-90 |
| Openfda › Package ndc › 6 | 51991-747-10 |
| Openfda › Package ndc › 7 | 51991-748-33 |
| Openfda › Package ndc › 8 | 51991-748-90 |
| Openfda › Package ndc › 9 | 51991-748-10 |
| Openfda › Package ndc › 10 | 51991-750-33 |
| Openfda › Package ndc › 11 | 51991-750-90 |
| Openfda › Package ndc › 12 | 51991-750-05 |
| Openfda › Package ndc › 13 | 51991-750-10 |
| Openfda › Product ndc › 1 | 51991-746 |
| Openfda › Product ndc › 2 | 51991-747 |
| Openfda › Product ndc › 3 | 51991-748 |
| Openfda › Product ndc › 4 | 51991-750 |
| Openfda › Generic name | DULOXETINE HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | DULOXETINE HYDROCHLORIDE |
| Openfda › Manufacturer name | Breckenridge Pharmaceutical, Inc. |
| Openfda › Application number | ANDA203088 |
| Openfda › Is original packager | true |
| Event id | 99108 |
| Address 1 | 200 Connell Dr Ste 4200 |
| Address 2 | N/A |
| Code info | Lot: 241180C, Exp. Date April 2027. |
| Postal code | 07922-2805 |
| Report date | 20260617 |
| Product type | Drugs |
| Product quantity | 14,729 bottles. |
| Reason for recall | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260604 |
| Initial firm notification | Letter |
| Center classification date | 20260608 |
Overview
- Recalling FirmBreckenridge Pharmaceutical, Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionNationwide within the United States