CLASS III Drug recall · Reported 27 Jan 2016 · FDA Enforcement Report
Phentermine Hydrochloride Capsules, USP, 15 mg recalled
PD-Rx Pharmaceuticals is recalling Phentermine Hydrochloride Capsules, USP, 15 mg, distributed nationwide in the US. The recall was initiated on 21 Jul 2015 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0574-2016
- FDA event ID
- 72941
- Recalling firm
- PD-Rx Pharmaceuticals, Oklahoma City, OK
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Jul 2015
- FDA classified
- 20 Jan 2016
- Reported
- 27 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
Timeline
| 21 Jul 2015 | Recall initiated by company | |
| 20 Jan 2016 | Classified by FDA | +183 days |
| 27 Jan 2016 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Is Phentermine Hydrochloride Capsules, USP, 15 mg recalled?
Yes. PD-Rx Pharmaceuticals recalled Phentermine Hydrochloride Capsules, USP, 15 mg on 21 Jul 2015. The recall is Class III and its status is Terminated. Recall number D-0574-2016.
Why was it recalled?
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Which lots are affected?
Lot #: a) H14C80, Exp 08/16; I14G36, Exp 09/16; b) H14A86, Exp 07/16; c) H14C83, Exp 08/16, K14A21, Exp 11/16; d) H14F25, Exp 08/16; e) L14C42, Exp 12/16.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from PD-Rx Pharmaceuticals
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DULoxetine DR USP, 30 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Nitrosamine Impurity | FL, MS, WI |
| Drug | CLASS II | Simvastatin USP 40 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin USP 20 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Simvastatin USP, 10 mg recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Montelukast Sodium USP, 10 mg-bottles recalled by PD-Rx Pharmaceuticals | PD-Rx Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
Other Phentermine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phentermine Hydrochloride Capsules, USP 30mg recalled by KVK TechPhentermine Hydrochloride | KVK Tech | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Phentermine Hydrochloride Capsules, USP 15mg recalledPhentermine | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Phentermine Capsules, 15 mg, a) bottle recalled by PD-Rx PharmaceuticalsPhentermine Hydrochloride | PD-Rx Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Phentermine HCL Capsules, USP 15 mg recalled by KVK-TechPhentermine Hydrochloride | KVK-Tech | Potency & Assay | Nationwide |
| Drug | CLASS III | Phentermine Hydrochloride Capsules, USP, 15 mg recalled by KVK-Tech | KVK-Tech | Potency & Assay | Nationwide |