Medications & Supplements/Prescription Drugs

Aidarex Pharmaceuticals LLC: Phentermine USP Capsules Recalled for Impurity Specification Failure

Agency Publication Date: September 13, 2017

Summary

Aidarex Pharmaceuticals LLC is recalling 35 bottles of Phentermine (USP Capsules, 15 mg) because the medication failed to meet purity specifications during long-term stability testing. This recall involves 30-count bottles that were distributed in California and Nevada. Consumers who have these capsules should check their batch numbers immediately as the medication contains unknown impurities that developed over time.

Risk

The medication was found to have unknown impurities and degradation products that exceeded safety specifications during a 30-month stability test. Taking medication that has degraded or contains unidentified impurities can lead to unpredictable side effects or reduced effectiveness.

What You Should Do

Check your Phentermine USP Capsules (15 mg, 30-count bottles) for the following batch and expiration combinations: Batch 47262-2 (Exp 8/31/2017), Batch 47262-3 (Exp 8/31/2017), Batch 47262-4 (Exp 12/30/17), Batch 47262-5 (Exp 12/31/17), Batch 47262-6 (Exp 12/31/17), and Batch 47262-7 (Exp 12/31/17).
Verify the NDC number 33261-0361-30 is printed on the bottle label to confirm if your product is part of this recall.
If you have an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on an alternative treatment.
Return any unused capsules to the pharmacy where you purchased them for a full refund.
Contact Aidarex Pharmaceuticals LLC at their Corona, California facility for further instructions regarding this voluntary recall.
For additional questions or to report a side effect, 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

Healthcare provider consultation and pharmacy refund.

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

Affected Products

Product: Phentermine, USP Capsules, 15 mg (30 count bottles)

Model:

33261-0361-30

D-1162-2017

Lot Numbers:

47262-2 (Exp 8/31/2017)

47262-3 (Exp 8/31/2017)

47262-4 (Exp 12/30/17)

47262-5 (Exp 12/31/17)

47262-6 (Exp 12/31/17)

47262-7 (Exp 12/31/17)

Date Ranges: Expiration 8/31/2017, Expiration 12/30/2017, Expiration 12/31/2017

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 78067

Status: Resolved

Manufacturer: Aidarex Pharmaceuticals LLC

Sold By: pharmacies

Manufactured In: United States

Units Affected: 35 bottles

Distributed To: California, Nevada

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

What You Should Do

Check your Phentermine USP Capsules (15 mg, 30-count bottles) for the following batch and expiration combinations: Batch 47262-2 (Exp 8/31/2017), Batch 47262-3 (Exp 8/31/2017), Batch 47262-4 (Exp 12/30/17), Batch 47262-5 (Exp 12/31/17), Batch 47262-6 (Exp 12/31/17), and Batch 47262-7 (Exp 12/31/17).

Verify the NDC number 33261-0361-30 is printed on the bottle label to confirm if your product is part of this recall.

If you have an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on an alternative treatment.

Return any unused capsules to the pharmacy where you purchased them for a full refund.

Contact Aidarex Pharmaceuticals LLC at their Corona, California facility for further instructions regarding this voluntary recall.

For additional questions or to report a side effect, 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, USP Capsules, 15 mg (30 count bottles)

Model:

33261-0361-30

D-1162-2017

Lot Numbers:

47262-2 (Exp 8/31/2017)

47262-3 (Exp 8/31/2017)

47262-4 (Exp 12/30/17)

47262-5 (Exp 12/31/17)

47262-6 (Exp 12/31/17)

47262-7 (Exp 12/31/17)

Date Ranges: Expiration 8/31/2017, Expiration 12/30/2017, Expiration 12/31/2017