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 Recalled by American Health Packaging Due to Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to...

Date: May 3, 2022
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 Capsules (10 x 10), 10-count blisters per card, 10 cards per carton, Unit Dose NDC 68084-446-11, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 68084-446-01

Quantity: 1603 cartons

Why Was This Recalled?

Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.

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 56 total recalls tracked by RecallDetector.

Related Recalls

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