CLASS III Drug recall · Reported 20 Sep 2017 · FDA Enforcement Report
Phentermine, USP Capsules, 15 mg recalled by Aidarex Pharmaceuticals
Aidarex Pharmaceuticals is recalling Phentermine, USP Capsules, 15 mg, distributed in California, Nevada. The recall was initiated on 5 Sep 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-1162-2017
- FDA event ID
- 78067
- Recalling firm
- Aidarex Pharmaceuticals, Corona, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Sep 2017
- FDA classified
- 13 Sep 2017
- Reported
- 20 Sep 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
Timeline
| 5 Sep 2017 | Recall initiated by company | |
| 13 Sep 2017 | Classified by FDA | +8 days |
| 20 Sep 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 Specification; out-of-specification results for individual unknown impurities at the 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, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
Where it was distributed
Distributed to the state of CA and NV.
Questions about this recall
Is Phentermine, USP Capsules, 15 mg recalled?
Yes. Aidarex Pharmaceuticals recalled Phentermine, USP Capsules, 15 mg on 5 Sep 2017. The recall is Class III and its status is Terminated. Recall number D-1162-2017.
Why was it recalled?
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Which lots are affected?
Batch 47262-2, 47262-3, exp 8/31/2017; 47262-4, exp 12/30/17, 47262-5, 47262-6, 47262-7, exp 12/31/17
Where was it sold?
Distributed to the state of CA and NV.
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 Aidarex Pharmaceuticals
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Enalapril Maleate, USP 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Enalapril Maleate, USP 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Enalapril Maleate, USP 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Ferrous Sulfate recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Other | FL |
| Drug | CLASS III | Enalapril Maleate Tablets, USP, 5MG recalled by Aidarex Pharmaceuticals | Aidarex Pharmaceuticals | Potency & Assay | FL |