Phentermine HCL Capsules — Class III drug recall D-1083-2017
Terminated recall by KVK-Tech, Inc., reported 2017-08-23, distributed nationwide. Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown imp
| Recall number | D-1083-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KVK-Tech, Inc., Newtown, PA, United States |
| Recall initiated | 2017-08-03 |
| Classified | 2017-08-11 |
| Reported by FDA | 2017-08-23 |
| Terminated | 2018-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 35,267 bottles |
| Reason classes | specification failure |
| NDC | 10702-0026, 10702-0026-01, 10702-0026-03, 10702-0026-10, 10702-0027, 10702-0027-01, 10702-0027-03, 10702-0027-10, 10702-0028, 10702-0028-01, 10702-0028-03, 10702-0028-10 |
| Expiration dates | 2017-09-20, 2017-12-20 |
Product
Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940
Reason for recall
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
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-1083-2017. 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.