Medications & Supplements/Prescription Drugs

AvKARE Nitrofurantoin Capsules Recalled for Failed Dissolution

Agency Publication Date: December 31, 2024

Summary

AvKARE has voluntarily recalled 1,016 cartons of Nitrofurantoin Capsules, USP (100 mg), a medication used to treat bacterial infections. The recall was issued because the capsules failed dissolution testing, meaning they may not dissolve properly in the body as required. Each recalled carton contains 50 unit-dose capsules.

Risk

If the capsules do not dissolve correctly, the patient may not receive the intended dose of medication. This could lead to the antibiotic being ineffective, resulting in a failure to treat the infection.

What You Should Do

The recalled product is AvKARE Nitrofurantoin Capsules, USP, 100 mg, sold in 50-count (5 x 10) unit-dose cartons with NDC number 50268-625-15.
Identify affected cartons by checking for lot number 47101 and an expiration date of February 2026 (02/2026) printed on the packaging.
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 AvKARE for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

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 (50-count carton)by AvKARE

Variants: 100 mg, Unit Dose (5 x 10)

Lot Numbers:

47101 (Exp. 02/2026)

NDC:

50268-625-15

Recall #: D-0168-2025; Manufactured for AvKARE, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95919

Status: Active

Manufacturer: AvKARE

Sold By: pharmacies; hospitals; healthcare providers

Manufactured In: United States

Units Affected: 1016 50-count 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

The recalled product is AvKARE Nitrofurantoin Capsules, USP, 100 mg, sold in 50-count (5 x 10) unit-dose cartons with NDC number 50268-625-15.

Identify affected cartons by checking for lot number 47101 and an expiration date of February 2026 (02/2026) printed on the packaging.

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 AvKARE for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.