FDA Drug recall D-0099-2025
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, I…
- FDA Drug
- Class II
- ongoing
- Published 2024-12-11
On 2024-12-11 the FDA classified a Class II recall of Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, I… by Amerisource Health Services, citing CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0099-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-11-14 |
| Published | 2024-12-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amerisource Health Services |
| Distribution | OH, PA, PR |
Product
Duloxetine Delayed-Release Capsules, USP, 20 mg, Rx only, 60 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-413-06
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Identifiers
| code_info | Lots: DT2023001A, DT2023009A, exp date Jan 31, 2025 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0099-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.