Medications & Supplements/Prescription Drugs

American Health Packaging Nitrofurantoin Capsules Recalled for Dissolution Failure

Agency Publication Date: May 18, 2022

Summary

American Health Packaging has voluntarily recalled 1,603 cartons of Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg. The recall was initiated because the medication failed dissolution testing, meaning the drug was released faster than the required specifications. This defect was identified at the start of testing for the repackaged lot.

Risk

When a medication releases its active ingredients faster than intended, it may not provide the consistent therapeutic effect required for treatment or could potentially lead to unexpected side effects. No incidents or injuries have been reported to date in connection with this recall.

What You Should Do

This recall affects Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, distributed in unit dose cartons containing 100 capsules (10 cards of 10 blisters).
Identify affected products by checking for lot number 1003829 with an expiration date of 1/31/23. The cartons carry Unit Dose NDC 68084-446-11, while individual product labeling may show NDC 68084-446-01.
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) or visit www.fda.gov/safety/recalls for additional information.

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: Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg (100-count carton)

Variants: 100 mg, Unit Dose, Capsules

Lot Numbers:

1003829 (Exp 1/31/23)

NDC:

68084-446-11

68084-446-01

Packaged as 10-count blisters per card, 10 cards per carton; Distributed by American Health Packaging, Columbus, Ohio.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90191

Status: Resolved

Manufacturer: American Health Packaging

Sold By: Pharmacies; Healthcare facilities

Manufactured In: United States

Units Affected: 1603 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 Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, distributed in unit dose cartons containing 100 capsules (10 cards of 10 blisters).

Identify affected products by checking for lot number 1003829 with an expiration date of 1/31/23. The cartons carry Unit Dose NDC 68084-446-11, while individual product labeling may show NDC 68084-446-01.

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) or visit www.fda.gov/safety/recalls for additional information.

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: Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg (100-count carton)

Variants: 100 mg, Unit Dose, Capsules

Lot Numbers:

1003829 (Exp 1/31/23)

NDC:

68084-446-11

68084-446-01

Packaged as 10-count blisters per card, 10 cards per carton; Distributed by American Health Packaging, Columbus, Ohio.