Phentermine Hydrochloride Capsules — Class III drug recall D-0574-2016
Terminated recall by PD-Rx Pharmaceuticals, Inc., reported 2016-01-27, distributed nationwide. Failed impurities/Degradation specifications: out of specification results for individual unknown and total im
| Recall number | D-0574-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PD-Rx Pharmaceuticals, Inc., Oklahoma City, OK, United States |
| Recall initiated | 2015-07-21 |
| Classified | 2016-01-20 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2016-12-23 |
| Distributed | Nationwide (US) |
| Quantity | 1,685 bottles |
| Reason classes | specification failure |
| NDC | 55289-0791, 55289-0791-07, 55289-0791-14, 55289-0791-15, 55289-0791-21, 55289-0791-28, 55289-0791-30, 55289-0791-60 |
Product
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC 55289-791-28), d) 30-count (NDC 55289-791-30), and e) 60-count (NDC 55289-791-60) bottles, Packaged by PD-RX Pharmaceuticals, INC Oklahoma City, OK 73127, MFG: KVK-TECH, INC Newtown, PA 18840.
Reason for recall
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
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-0574-2016. 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.