Recalls / Class II
Class IID-0446-2025
Product
Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd. By: KVK-Tech, Inc., Newtown, PA, 18940, Made in USA, NDC 10702-028-01.
- Brand name
- Phentermine Hydrochloride
- Generic name
- Phentermine Hydrochloride
- Active ingredient
- Phentermine Hydrochloride
- Route
- Oral
- NDCs
- 10702-026, 10702-027, 10702-028
- FDA application
- ANDA040886
- Affected lot / code info
- Lot#: 18350A, 18351A, Exp 6/30/2027
Why it was recalled
cGMP deviations
Recalling firm
- Firm
- KVK Tech, Inc.
- Manufacturer
- KVK-Tech, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 110 Terry Dr, N/A, Newtown, Pennsylvania 18940-3427
Distribution
- Quantity
- 9680 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2025-05-09
- FDA classified
- 2025-05-21
- Posted by FDA
- 2025-05-28
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0446-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.