CLASS III Drug recall · Reported 30 Aug 2017 · FDA Enforcement Report
Phentermine Capsules, 15 mg, a) bottle recalled by PD-Rx Pharmaceuticals
PD-Rx Pharmaceuticals is recalling Phentermine Capsules, 15 mg, a) bottle (, distributed nationwide in the US. The recall was initiated on 11 Aug 2017 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-1118-2017
- FDA event ID
- 77915
- Recalling firm
- PD-Rx Pharmaceuticals, Oklahoma City, OK
- Manufacturer
- PD-Rx Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Aug 2017
- FDA classified
- 23 Aug 2017
- Reported
- 30 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 11 Aug 2017 | Recall initiated by company | |
| 23 Aug 2017 | Classified by FDA | +12 days |
| 30 Aug 2017 | 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 impurities at 30th month Room Temperature Retained Sample stabilities test .
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 Capsules, 15 mg, a) 7-count bottle (NDC 55289-791-07), b) 14-count bottle ( NDC 55289-791-14), c) 21-count bottle (NDC 55289-791-21), d) 30-count bottle (NDC 55289-791-30), e) 60-count bottle (NDC 55289-791-60), Packaged by PD-Rx Pharmaceuticals, Incorporated, Oklahoma City, OK. 73127 Mfg: KVK-Tech, Inc. Newtown, PA 18940
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
Which lots are affected?
Lots: a) H15E22, Exp. 8/31/17; J15E02, Exp. 10/31/17. b) J15A53, Exp. 10/31/17; D16C78, Exp.12/31/17; c)J15D54, Exp. 10/31/17; d)H15B60, Exp. 8/31/17; e) J15A49, Exp. 10/31/17; C16A14, Exp. 12/31/17.
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 26 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 8| 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, 30 mg capsules, Rx only recalled by Calvin Scott & Company | Calvin Scott | Potency & Assay | 5 states |
| Drug | CLASS II | Phentermine Hydrochloride Capsules, USP 15mg recalledPhentermine | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Phentermine, USP Capsules, 15 mg recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | CA, NV |
| Drug | CLASS III | Phentermine HCL Capsules, USP 15 mg recalled by KVK-TechPhentermine Hydrochloride | Kvk-Tech | Potency & Assay | Nationwide |