Medications & Supplements/Prescription Drugs

Mylan Pharmaceuticals Inc.: Fexofenadine HCl Tablets Recalled for Elevated Impurities

Agency Publication Date: January 31, 2019

Summary

Mylan Pharmaceuticals Inc. is recalling approximately 88,090 bottles of Fexofenadine HCl (the generic version of Allegra), a 180 mg allergy medication. This recall includes both 30-count and 500-count bottles after routine stability testing showed slightly elevated levels of a degradation impurity. This means the chemical composition of the drug changed over time beyond approved safety limits. If you have this medication, you should consult your pharmacist or doctor to discuss alternatives and your treatment plan.

Risk

Routine testing discovered that a chemical byproduct of the drug's breakdown was slightly higher than the allowed safety specification. While no injuries have been reported, impurities in medication can potentially impact the drug's quality and long-term safety profile.

What You Should Do

Check your medicine cabinet for 'Fexofenadine HCl Tablets, USP, 180 mg' manufactured by Mylan Pharmaceuticals Inc.
Identify if your bottle is affected by checking the lot numbers and NDC codes. For 30-count bottles (NDC 0378-0782-93), look for lot numbers 3085490 or 3085491. For 500-count bottles (NDC 0378-0782-05), look for lot numbers 3085492, 3085493, 3085494, 3085495, or 3085496.
Confirm that the expiration date on the affected bottle is April 2019 (Exp 04/19).
Contact your healthcare provider or pharmacist for guidance regarding the continued use of this medication and to discuss alternative treatments.
Return any unused product to the pharmacy where you purchased it for a refund and contact Mylan Pharmaceuticals Inc. at 781 Chestnut Ridge Rd, Morgantown, West Virginia, 26505-2730 for further instructions.
For additional questions about this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

Full Refund

Consultation and Refund

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

Affected Products

Product: Fexofenadine HCl Tablets, USP, 180 mg (30-count bottles)

Model:

NDC 0378-0782-93

Lot Numbers:

3085490 (Exp 04/19)

3085491 (Exp 04/19)

Date Ranges: Exp 04/19

Product: Fexofenadine HCl Tablets, USP, 180 mg (500-count bottles)

Model:

NDC 0378-0782-05

Lot Numbers:

3085492 (Exp 04/19)

3085493 (Exp 04/19)

3085494 (Exp 04/19)

3085495 (Exp 04/19)

3085496 (Exp 04/19)

Date Ranges: Exp 04/19

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81930

Status: Resolved

Manufacturer: Mylan Pharmaceuticals Inc.

Sold By: Pharmacies nationwide

Manufactured In: United States

Units Affected: 88,090 bottles

Distributed To: Nationwide

Agency Last Updated: February 4, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 medicine cabinet for 'Fexofenadine HCl Tablets, USP, 180 mg' manufactured by Mylan Pharmaceuticals Inc.

Identify if your bottle is affected by checking the lot numbers and NDC codes. For 30-count bottles (NDC 0378-0782-93), look for lot numbers 3085490 or 3085491. For 500-count bottles (NDC 0378-0782-05), look for lot numbers 3085492, 3085493, 3085494, 3085495, or 3085496.

Confirm that the expiration date on the affected bottle is April 2019 (Exp 04/19).

Contact your healthcare provider or pharmacist for guidance regarding the continued use of this medication and to discuss alternative treatments.

Return any unused product to the pharmacy where you purchased it for a refund and contact Mylan Pharmaceuticals Inc. at 781 Chestnut Ridge Rd, Morgantown, West Virginia, 26505-2730 for further instructions.

For additional questions about this recall, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Affected Products

Product: Fexofenadine HCl Tablets, USP, 180 mg (30-count bottles)

Model:

NDC 0378-0782-93

Lot Numbers:

3085490 (Exp 04/19)

3085491 (Exp 04/19)

Date Ranges: Exp 04/19

Product: Fexofenadine HCl Tablets, USP, 180 mg (500-count bottles)

Model:

NDC 0378-0782-05

Lot Numbers:

3085492 (Exp 04/19)

3085493 (Exp 04/19)

3085494 (Exp 04/19)

3085495 (Exp 04/19)

3085496 (Exp 04/19)

Date Ranges: Exp 04/19