Nitrofurantoin Capsules (American Health) – Cross Contamination (2018)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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)
Brand
AMERICAN HEALTH PACKAGING
Lot Codes / Batch Numbers
Lot#: 180310, 180612, Exp 03/31/20
Products Sold
Lot#: 180310, 180612, Exp 03/31/20
AMERICAN HEALTH PACKAGING is recalling Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Unit Dose Blisters, Rx on due to 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. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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."
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026