Medications & Supplements/Prescription Drugs

PD-Rx Pharmaceuticals, Inc.: Phentermine Capsules Recalled for Failing Impurity and Degradation Tests

Agency Publication Date: September 12, 2017

Summary

PD-Rx Pharmaceuticals, Inc. is recalling 3,440 bottles of Phentermine (15 mg) capsules, a prescription weight-loss medication. The recall was initiated because the drug failed quality testing for unknown impurities and degradation levels during a 30-month stability check. These capsules were manufactured by KVK-Tech, Inc. and distributed nationwide in various bottle sizes ranging from 7-count to 60-count containers.

Risk

The presence of unknown impurities and degradation products at levels higher than allowed specifications means the medication may not be as safe or effective as intended over time. While the risk level is considered low, using drugs that exceed impurity limits can lead to unpredictable side effects or reduced therapeutic benefit.

What You Should Do

Check your Phentermine 15 mg capsule bottle for the following specific NDC numbers and lot identifiers: NDC 55289-791-07 (7-count) with lot H15E22 (Exp. 8/31/17) or J15E02 (Exp. 10/31/17); NDC 55289-791-14 (14-count) with lot J15A53 (Exp. 10/31/17) or D16C78 (Exp. 12/31/17); NDC 55289-791-21 (21-count) with lot J15D54 (Exp. 10/31/17); NDC 55289-791-30 (30-count) with lot H15B60 (Exp. 8/31/17); or NDC 55289-791-60 (60-count) with lot J15A49 (Exp. 10/31/17) or C16A14 (Exp. 12/31/17).
If your medication matches any of the affected lot numbers and expiration dates, contact your healthcare provider or pharmacist immediately for guidance on continued use or to obtain a replacement prescription.
Return any remaining unused capsules to the pharmacy or place of purchase to receive a refund.
Contact PD-Rx Pharmaceuticals, Inc. at their Oklahoma City office at 727 N Ann Arbor Ave, Oklahoma City, OK 73127 for further instructions regarding the return of the product.
For additional questions or to report adverse reactions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug recall remedy for unknown impurities.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Phentermine Capsules, 15 mg (7-count bottle)

Model:

NDC 55289-791-07

Lot Numbers:

H15E22 (Exp. 8/31/17)

J15E02 (Exp. 10/31/17)

Date Ranges: Exp. 8/31/17, Exp. 10/31/17

Product: Phentermine Capsules, 15 mg (14-count bottle)

Model:

NDC 55289-791-14

Lot Numbers:

J15A53 (Exp. 10/31/17)

D16C78 (Exp. 12/31/17)

Date Ranges: Exp. 10/31/17, Exp. 12/31/17

Product: Phentermine Capsules, 15 mg (21-count bottle)

Model:

NDC 55289-791-21

Lot Numbers:

J15D54 (Exp. 10/31/17)

Date Ranges: Exp. 10/31/17

Product: Phentermine Capsules, 15 mg (30-count bottle)

Model:

NDC 55289-791-30

Lot Numbers:

H15B60 (Exp. 8/31/17)

Date Ranges: Exp. 8/31/17

Product: Phentermine Capsules, 15 mg (60-count bottle)

Model:

NDC 55289-791-60

Lot Numbers:

J15A49 (Exp. 10/31/17)

C16A14 (Exp. 12/31/17)

Date Ranges: Exp. 10/31/17, Exp. 12/31/17

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77915

Status: Resolved

Manufacturer: PD-Rx Pharmaceuticals, Inc.

Manufactured In: United States

Units Affected: 3440 bottles

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Check your Phentermine 15 mg capsule bottle for the following specific NDC numbers and lot identifiers: NDC 55289-791-07 (7-count) with lot H15E22 (Exp. 8/31/17) or J15E02 (Exp. 10/31/17); NDC 55289-791-14 (14-count) with lot J15A53 (Exp. 10/31/17) or D16C78 (Exp. 12/31/17); NDC 55289-791-21 (21-count) with lot J15D54 (Exp. 10/31/17); NDC 55289-791-30 (30-count) with lot H15B60 (Exp. 8/31/17); or NDC 55289-791-60 (60-count) with lot J15A49 (Exp. 10/31/17) or C16A14 (Exp. 12/31/17).

If your medication matches any of the affected lot numbers and expiration dates, contact your healthcare provider or pharmacist immediately for guidance on continued use or to obtain a replacement prescription.

Return any remaining unused capsules to the pharmacy or place of purchase to receive a refund.

Contact PD-Rx Pharmaceuticals, Inc. at their Oklahoma City office at 727 N Ann Arbor Ave, Oklahoma City, OK 73127 for further instructions regarding the return of the product.

For additional questions or to report adverse reactions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Phentermine Capsules, 15 mg (7-count bottle)

Model:

NDC 55289-791-07

Lot Numbers:

H15E22 (Exp. 8/31/17)

J15E02 (Exp. 10/31/17)

Date Ranges: Exp. 8/31/17, Exp. 10/31/17

Product: Phentermine Capsules, 15 mg (14-count bottle)

Model:

NDC 55289-791-14

Lot Numbers:

J15A53 (Exp. 10/31/17)

D16C78 (Exp. 12/31/17)

Date Ranges: Exp. 10/31/17, Exp. 12/31/17

Product: Phentermine Capsules, 15 mg (21-count bottle)

Model:

NDC 55289-791-21

Lot Numbers:

J15D54 (Exp. 10/31/17)

Date Ranges: Exp. 10/31/17

Product: Phentermine Capsules, 15 mg (30-count bottle)

Model:

NDC 55289-791-30

Lot Numbers:

H15B60 (Exp. 8/31/17)

Date Ranges: Exp. 8/31/17

Product: Phentermine Capsules, 15 mg (60-count bottle)

Model:

NDC 55289-791-60

Lot Numbers:

J15A49 (Exp. 10/31/17)

C16A14 (Exp. 12/31/17)

Date Ranges: Exp. 10/31/17, Exp. 12/31/17