RecallRadar

FDA Drug recall D-0446-2025

Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd

On 2025-05-28 the FDA classified a Class II recall of Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd by Kvk Tech, citing cGMP deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0446-2025
ClassificationClass II
Statusongoing
Initiated2025-05-09
Published2025-05-28
Last updated2026-09-13 11:52 UTC
CompanyKvk Tech
DistributionUS

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.

Reason

cGMP deviations

Identifiers

ndc10702-026-03
ndc10702-026-01
ndc10702-026-10
ndc10702-027-03
ndc10702-027-01
ndc10702-027-10
ndc10702-028-03
ndc10702-028-01
ndc10702-028-10
code_infoLot#: 18350A, 18351A, Exp 6/30/2027

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0446-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.