Duloxetine Delayed-Release Cap USP 30mg — Class II drug recall D-0505-2024
Ongoing recall by Preferred Pharmaceuticals, Inc., reported 2024-05-29, distributed in CA, CT, FL, KS, OK. CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
| Recall number | D-0505-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Preferred Pharmaceuticals, Inc., Anaheim, CA, United States |
| Recall initiated | 2024-05-10 |
| Classified | 2024-05-21 |
| Reported by FDA | 2024-05-29 |
| Distributed | CA, CT, FL, KS, OK |
| Reason classes | cgmp, specification failure |
| NDC | 68788-9301-03 |
| Lot numbers | J2022G |
| Expiration dates | 2025-01-01 |
Product
Duloxetine Delayed-Release Cap USP 30mg, 30-count bottle, Rx only, Preferred Pharmaceutcals, Inc., NDC 68788-9301-03
Reason for recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0505-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.