Use cautionDrug recall · FDA · Published January 7, 2021
American Health Packaging Recalls Nitrofurantoin Capsules Due to Dissolution Failure
American Health Packaging is recalling Nitrofurantoin Capsules USP 100 mg due to failed dissolution specifications. Check your lot number and expiration date.
📍Recalling firmAmerican Health Packaging2550 John Glenn Ave Ste A · Columbus, OH 43217-1188
✎ GovInfoNow plain-language explainer
American Health Packaging has recalled Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, because the product failed dissolution specifications. This means the capsules may not release the medication properly in the body, potentially reducing its effectiveness for treating urinary tract infections. The recall affects 1,948 cartons distributed nationwide. Read more at govinfonow.com/recall/36555-american-health-packaging-recalls-nitrofurantoin-capsules-due-to-dissolution-failure.
“American Health Packaging Recalls Nitrofurantoin Capsules Due to Dissolution Failure.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36555-american-health-packaging-recalls-nitrofurantoin-capsules-due-to-dissolution-failure. Based on FDA recall #D-0232-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0232-2021%22&limit=1).
The FDA announced on Jan. 7, 2021, that American Health Packaging voluntarily recalled Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg due to failed dissolution specifications. The recall affects 1,948 cartons distributed nationwide.
How to tell if you have it
Brand: American Health Packaging
Product: Nitrofurantoin Capsules 100 mg
NDC Carton: 68084-446-01
NDC Blister Card: 68084- 446-11
Lot #: 193757
Expiration Date: Exp 1/31/2022
The hazard
The capsules failed to meet dissolution specifications, which could result in the drug not releasing properly. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show American Health Packaging has 41 other recalls on record since July 23, 2012. Other recent recalls of similar products include Golden State NIACIN Extended-Release Tablets Recall (May 29, 2026), Mylan Recalls Amnesteem Isotretinoin Capsules Due to Dissolution Failure (Feb. 24, 2026), and Inventia Chlorthalidone Recall (Sept. 3, 2026).
How to tell if you have this one
Look for Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, in cartons containing 100 capsules (10 capsules x 10 blister cards). Check the NDC Carton number 68084-446-01 or NDC Blister Card number 68084-446-11. The specific recalled lot is #193757 with an expiration date of 1/31/2022.
Brand
American Health Packaging
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Your Medication
Verify if your Nitrofurantoin capsules match the brand, lot number #193757, and expiration date of 1/31/2022.
Contact Your Pharmacist
If you have the recalled product, contact your pharmacy or healthcare provider to discuss replacing it with a different manufacturer's product.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 19 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0232-2021 (January 7, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0232-2021 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.