CLASS III Drug recall · Reported 2 Sep 2015 · FDA Enforcement Report
Phentermine Hydrochloride Capsules, USP, 15 mg recalled by KVK-Tech
KVK-Tech is recalling Phentermine Hydrochloride Capsules, USP, 15 mg, distributed nationwide in the US. The recall was initiated on 14 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-1371-2015
- FDA event ID
- 71726
- Recalling firm
- KVK-Tech, Newtown, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 14 Jul 2015
- FDA classified
- 25 Aug 2015
- Reported
- 2 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 14 Jul 2015 | Recall initiated by company | |
| 25 Aug 2015 | Classified by FDA | +42 days |
| 2 Sep 2015 | Published in enforcement report | +8 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) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
Where it was distributed
Nationwide
Questions about this recall
Is Phentermine Hydrochloride Capsules, USP, 15 mg recalled?
Yes. KVK-Tech recalled Phentermine Hydrochloride Capsules, USP, 15 mg on 14 Jul 2015. The recall is Class III and its status is Terminated. Recall number D-1371-2015.
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) 11957A, Exp 04/2017; b) 11956A, Exp 04/2017
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 KVK-Tech
All 15| 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 | Indomethacin Extended-Release Capsules USP, 75 mg recalled by KVK TechIndomethacin | KVK Tech | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Betaxolol Tablets, USP 10 mg recalled by KVK-TechBetaxolol Hydrochloride | KVK-Tech | Other | Nationwide |
| Drug | CLASS I | Atovaquone Oral Suspension, USP, 750 mg recalled by KVK-TechAtovaquone Oral Suspension | KVK-Tech | Temperature Abuse | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Homatropine Methlybromide recalledHydrocodone Bitartrate And Homatropine Methylbromide | KVK-Tech | Potency & Assay | 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 recalledPhentermine Hydrochloride | PD-Rx Pharmaceuticals | Potency & Assay | Nationwide |