Medications & Supplements/Prescription Drugs

American Health Packaging Benzonatate Capsules Recalled for Superpotency

Agency Publication Date: January 19, 2024

Summary

American Health Packaging is recalling 6,344 cartons of Benzonatate Capsules, USP, 100 mg. The recall was issued because the medication was found to be superpotent, meaning the capsules contained a slightly higher amount of the active drug than allowed by specifications. Benzonatate is a prescription medication used to relieve coughs.

Risk

Taking a superpotent dose of benzonatate may lead to an increased risk of side effects or adverse reactions. No injuries or incidents have been reported to date.

What You Should Do

This recall affects Benzonatate Capsules, USP, 100 mg, sold in cartons of 100 capsules (consisting of 10 unit-dose cards with 10 capsules each) under the American Health Packaging brand. Affected packages are marked with Lot # 1014208 and an expiration date of March 31, 2025.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards)by American Health Packaging

Variants: 100 mg, Capsule

Lot Numbers:

1014208 (Exp Mar/31/2025)

NDC:

68084-214-01

68084-214-11

Distributed by American Health Packaging. Carton NDC is 68084-214-01; Individual Dose NDC is 68084-214-11.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93778

Status: Active

Manufacturer: Amerisource Health Services LLC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 6,344 cartons

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

What You Should Do

This recall affects Benzonatate Capsules, USP, 100 mg, sold in cartons of 100 capsules (consisting of 10 unit-dose cards with 10 capsules each) under the American Health Packaging brand. Affected packages are marked with Lot # 1014208 and an expiration date of March 31, 2025.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards)by American Health Packaging

Variants: 100 mg, Capsule

Lot Numbers:

1014208 (Exp Mar/31/2025)

NDC:

68084-214-01

68084-214-11

Distributed by American Health Packaging. Carton NDC is 68084-214-01; Individual Dose NDC is 68084-214-11.