Medications & Supplements/Prescription Drugs

American Health Packaging: Nitrofurantoin Capsules Recalled for Failed Dissolution Specifications

Agency Publication Date: January 15, 2021

Summary

American Health Packaging is recalling 1,948 cartons of Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, because the drug failed dissolution testing. This means the medication may not break down properly in the body, which could prevent it from being absorbed correctly to treat infections. The recalled capsules were distributed nationwide in 100-count cartons containing 10 blister cards.

Risk

If the medication fails to dissolve as required, the patient may not receive the full therapeutic dose. This could lead to a lack of effectiveness in treating bacterial infections, potentially allowing the infection to worsen or persist.

What You Should Do

Check your medication packaging for Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, in 100-count cartons (10 capsules x 10 blister cards).
Look for NDC Carton number 68084-446-01 or NDC Blister Card number 68084-446-11.
Verify the lot number and expiration date on the packaging: Check for Lot # 193757 with an expiration date of 1/31/2022.
Contact your healthcare provider or pharmacist immediately for guidance if you are using medication from this affected lot.
Return any unused product from this lot to the pharmacy where it was purchased for a refund.
For additional questions, 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

Contact healthcare provider and return product to pharmacy.

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

Affected Products

Product: Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton

Model:

NDC Carton: 68084-446-01

NDC Blister Card: 68084-446-11

Recall #: D-0232-2021

Lot Numbers:

193757 (Exp 1/31/2022)

Date Ranges: Expiration date 1/31/2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87154

Status: Resolved

Manufacturer: American Health Packaging

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 1948 cartons

Distributed To: Nationwide

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 medication packaging for Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, in 100-count cartons (10 capsules x 10 blister cards).

Look for NDC Carton number 68084-446-01 or NDC Blister Card number 68084-446-11.

Verify the lot number and expiration date on the packaging: Check for Lot # 193757 with an expiration date of 1/31/2022.

Contact your healthcare provider or pharmacist immediately for guidance if you are using medication from this affected lot.

Return any unused product from this lot to the pharmacy where it was purchased for a refund.

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