American Health Packaging Nitrofurantoin Capsules Recall

Why it was recalled

Failed Dissolution Specifications

Product description

Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11

Lot numbers, UPCs & expiration codes

Lot # 193757, Exp 1/31/2022

Where it was sold

Nationwide USA

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0232-2021
Classification: Class II
Status: Terminated
Recall initiated: Jan 7, 2021
FDA report date: Jan 27, 2021
Quantity: 1948 cartons
Recall type: Voluntary: Firm initiated
Recalling firm: American Health Packaging

Original FDA data

Every field from FDA enforcement report D-0232-2021, exactly as published.

Show all FDA fields

City: Columbus
State: OH
Status: Terminated
Country: United States
Event ID: 87154
Address: 2550 John Glenn Ave Ste A
Code information: Lot # 193757, Exp 1/31/2022
Postal code: 43217-1188
Report date: Jan 27, 2021
Product type: Drugs
Recall number: D-0232-2021
Classification: Class II
Recalling firm: American Health Packaging
Product quantity: 1948 cartons
Termination date: Aug 3, 2022
Reason for recall: Failed Dissolution Specifications
Voluntary / mandated: Voluntary: Firm initiated
Product description: Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11
Distribution pattern: Nationwide USA
Recall initiation date: Jan 7, 2021
Initial firm notification: Letter
Center classification date: Jan 15, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0232-2021, published Jan 27, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.