“Alvogen Nitrofurantoin Recall: Failed Dissolution.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44780-alvogen-inc-recalls-nitrofurantoin-monohydrate-macrocrystals-capsules-100-mg-100. Based on FDA recall #D-1082-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1082-2015%22&limit=1).
The FDA announced on April 21, 2015, that Alvogen, Inc. is recalling Nitrofurantoin Monohydrate/Macrocrystals Capsules due to failed dissolution specifications. The recall affects 13,392 bottles distributed nationwide and in Puerto Rico.
The product failed dissolution specifications at the 6-month time point. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Alvogen, Inc. has issued 9 other recalls since August 28, 2014. Recent brand recalls include an Alvogen Thyro-Tabs mix-up risk on December 31, 2025, and a Fentanyl patch overdose risk on January 31, 2025. Other recent recalls of similar products include AvKARE Amantadine Capsules (February 13, 2026), Inventia Chlorthalidone (September 3, 2026), and Ajanta Pharma Ranolazine (September 17, 2026).
How to tell if you have this one
Check your medication bottle for the brand name Alvogen, Inc. Look for NDC 47781-303-01 and Lot number 457529. The expiration date on the bottle should be 08/2016.
Brand
Alvogen
Category
Drug
Based on the official FDA remedy
What to do — step by step
Contact Your Pharmacist
Reach out to your pharmacy or healthcare provider to discuss replacing the recalled medication.
Verify Lot Number
Confirm that your bottle matches Lot 457529 and expires in 08/2016 before taking any action.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 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-1082-2015 (April 21, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1082-2015 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.