The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0446-2025·Announced 2025-05-28

Phentermine Hydrochloride Capsules 30mg Recalled for cGMP Deviations

KVK Tech, Inc. is recalling 9,680 bottles of Phentermine Hydrochloride Capsules 30mg nationwide due to cGMP (current Good Manufacturing Practice) deviations. The recall is voluntary and firm-initiated.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The source indicates an FDA Class II recall for cGMP deviations. No hospitalizations, illnesses, or injuries are reported in the source text. cGMP deviations are manufacturing/process issues rather than direct health hazards, placing this in the Moderate category.

Plain-English summary

KVK Tech, Inc. is recalling Phentermine Hydrochloride Capsules, USP 30mg in 100-count bottles (NDC 10702-028-01) distributed nationwide. The recall affects lot numbers 18350A and 18351A with an expiration date of 6/30/2027, totaling approximately 9,680 bottles.

The recall has been initiated due to cGMP (current Good Manufacturing Practice) deviations. This is a voluntary, firm-initiated recall.

Consumers who have obtained this medication should contact their pharmacist or healthcare provider for guidance. Patients should not stop taking the medication without consulting their healthcare provider.

The recalled product

Product
PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
Brand
PHENTERMINE HYDROCHLORIDE
Manufacturer
KVK Tech, Inc.
Category
Drug — Prescription Oral Medication
Hazard
Affected units
9,680

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 (3)

  • Lot#: 18350A
  • 18351A
  • Exp 6/30/2027

UPCs (3)

  • 0310702027107
  • 0310702028104
  • 0310702026100

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by KVK Tech, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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