Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals) Recalled by AMERICAN HEALTH PACKAGING Due to Cross contamination with other products: This sub-recall is...

Date: November 9, 2018
Company: AMERICAN HEALTH PACKAGING
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact AMERICAN HEALTH PACKAGING directly.

Affected Products

Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx only, Amerisource Health Services DBA American Health Packaging, 2550-A John Glenn Avenue Columbus, OH 43217, NDC 68084-446-01 (Individual Dose NDC: 68064-446-11)

Quantity: 4508 blister packs

Why Was This Recalled?

Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About AMERICAN HEALTH PACKAGING

AMERICAN HEALTH PACKAGING has 3 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report