Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-1118-2017·Announced 2017-08-30

PD-Rx Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures

PD-Rx Pharmaceuticals is recalling 3,440 bottles of Phentermine Hydrochloride capsules because stability tests showed out-of-specification unknown impurities.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 recall is classified as FDA Class III, which typically corresponds to a severity score of 1 or 2. A score of 2 is assigned as it involves a prescription drug with a quality specification failure (impurities) that is not likely to cause adverse health consequences but requires removal from the market.

Plain-English summary

PD-Rx Pharmaceuticals, Inc. is recalling 3,440 bottles of Phentermine Hydrochloride Capsules, 15 mg. The affected products are available in 7-count, 14-count, 21-count, 30-count, and 60-count bottles. The recall is being conducted because out-of-specification results were found for individual unknown impurities during the 30th month Room Temperature Retained Sample stability test.

The recalled products were distributed nationwide. Specific lot numbers and expiration dates are listed in the official recall notice. The products were packaged by PD-Rx Pharmaceuticals, Incorporated, in Oklahoma City, OK, and manufactured by KVK-Tech, Inc. in Newtown, PA.

Consumers who have these products should stop using them and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.

The recalled product

Product: PHENTERMINE HYDROCHLORIDE (PHENTERMINE HYDROCHLORIDE)
Brand: PHENTERMINE HYDROCHLORIDE
Manufacturer: PD-Rx Pharmaceuticals, Inc.
Category: Drug — Prescription Drug
Hazard: impurities
Affected units: 3,440

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 (12)

Lots: a) H15E22
Exp. 8/31/17
J15E02
Exp. 10/31/17. b) J15A53
Exp. 10/31/17
D16C78
Exp.12/31/17
c)J15D54
d)H15B60
e) J15A49
C16A14
Exp. 12/31/17.

UPCs (1)

0355289791607

Distribution

Distributed nationwide across the United States.

Same brand · PHENTERMINE HYDROCHLORIDE

Moderate
Phentermine Hydrochloride Capsules 30mg Recalled for cGMP Deviations
FDA (Drugs) · 2025-05-28
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KVK-Tech Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures
FDA (Drugs) · 2017-08-23
Low
PD-Rx Recalls Phentermine Hydrochloride Capsules Due to Impurity Failures
FDA (Drugs) · 2016-01-27

Same manufacturer · PD-Rx Pharmaceuticals, Inc.

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