FDA Drug recall D-0100-2025
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Man…
- 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, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Man… 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-0100-2025 |
| 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, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
Reason
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Identifiers
| code_info | a) 30 count; Lot, expiry: DT3023019B, DT3023020A, exp 01/31/2025 b) 1000 count; Lot, expiry: DTB23098A, exp 08/31/2025 |
|---|
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-0100-2025%22
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