CLASS III Drug recall · Reported 23 Aug 2017 · FDA Enforcement Report
Phentermine HCL Capsules, USP 15 mg recalled by KVK-Tech
Kvk-Tech is recalling Phentermine HCL Capsules, USP 15 mg, distributed nationwide in the US. The recall was initiated on 3 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-1083-2017
- FDA event ID
- 77878
- Recalling firm
- Kvk-Tech, Newtown, PA
- Manufacturer
- KVK-Tech, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 3 Aug 2017
- FDA classified
- 11 Aug 2017
- Reported
- 23 Aug 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 3 Aug 2017 | Recall initiated by company | |
| 11 Aug 2017 | Classified by FDA | +8 days |
| 23 Aug 2017 | Published in enforcement report | +12 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 obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability 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 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
Where it was distributed
Nationwide in the United States
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Which lots are affected?
Lot # a):12322A, 12323B, 12324A, Exp. Sep 2017; 12455A, Exp. Dec 2017; b) 12323A, Exp. Sep 2017; 12456A, Exp. Dec 2017
Where was it sold?
Nationwide in the United States
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 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 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 Capsules, 15 mg, a) bottle recalled by PD-Rx PharmaceuticalsPhentermine Hydrochloride | PD-Rx Pharmaceuticals | Potency & Assay | Nationwide |