Aidarex Recalls Phentermine Capsules Due to Impurity Test Failures
Aidarex Pharmaceuticals is recalling 35 bottles of Phentermine 15 mg capsules because they failed impurity specifications during stability testing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Aidarex Pharmaceuticals LLC is recalling 35 bottles of Phentermine, USP Capsules, 15 mg, 30 count bottles. The product is prescription-only and was packaged by Aidarex Pharmaceuticals in Corona, CA, and manufactured by KVK-TECH INC. in Newtown, PA.
The recall was initiated because the product failed impurities/degradation specifications. Specifically, out-of-specification results were found for individual unknown impurities during the 30-month Room Temperature Retained Sample stability test. The affected batches are 47262-2, 47262-3, 47262-4, 47262-5, 47262-6, and 47262-7, with expiration dates ranging from August 31, 2017, to December 31, 2017.
The product was distributed to the states of California and Nevada. Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for instructions on how to return the medication or obtain a replacement.
The recalled product
- Product
- 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
- Manufacturer
- Aidarex Pharmaceuticals LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 35
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- 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
Distribution
Related recalls
Same manufacturer · Aidarex Pharmaceuticals LLC
See all →- ModerateAidarex Recalls Enalapril Maleate Due to Out-of-Specification Degradation Product
FDA (Drugs) · 2018-08-01
- LowAidarex Recalls Enalapril Maleate Due to Out-of-Specification Degradation Product
FDA (Drugs) · 2018-08-01
- LowAidarex Recalls Enalapril Maleate 2.5mg Due to Stability Issues
FDA (Drugs) · 2018-08-01
- LowAidarex Recalls Ferrous Sulfate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2018-05-23
- ModerateAidarex Recalls Enalapril Maleate Tablets Due to Impurity Failures
FDA (Drugs) · 2017-11-01
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17