Duloxetine Delayed-release Capsules USP — Class II drug recall D-0055-2018
Terminated recall by AVKARE Inc., reported 2017-11-08, distributed nationwide. Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
| Recall number | D-0055-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AVKARE Inc., Pulaski, TN, United States |
| Recall initiated | 2017-10-06 |
| Classified | 2017-10-27 |
| Reported by FDA | 2017-11-08 |
| Terminated | 2019-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 274 cartons |
| Reason classes | specification failure |
| NDC | 50268-0283-15 |
| Lot numbers | 11/18, 18103 |
Product
Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dose per carton, unit dose blister UPC 5026828311), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-283-15.
Reason for recall
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
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-0055-2018. 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.