Romark Recalls Alinia Powder Due to Stability Failures
Romark Laboratories recalls Alinia powder for oral suspension due to failed stability specifications. Check lot numbers and expiration dates for affected batches.
Recall notice
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Contact the company
What happened, in plain English
Romark Laboratories, L.C. is recalling Alinia (nitazoxanide) powder for oral suspension because the product failed to meet long-term stability specifications for viscosity. The recall affects specific lots manufactured for Lupin Pharmaceuticals Inc. distributed nationwide. No other hazards or injuries are mentioned in the record. Read more at govinfonow.com/recall/44726-romark-laboratories-l-c-recalls-alinia-nitazoxanide-powder-for-oral.
Source Summary by GovInfoNow · govinfonow.com/recall/44726-romark-laboratories-l-c-recalls-alinia-nitazoxanide-powder-for-oral · Updated October 12, 2026 · FDA enforcement record: FDA #D-0983-2015
Cite this page
“Romark Recalls Alinia Powder Due to Stability Failures.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/44726-romark-laboratories-l-c-recalls-alinia-nitazoxanide-powder-for-oral. Based on FDA recall #D-0983-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0983-2015%22&limit=1).
Why it’s dangerous
The product failed to meet 12-month long-term stability specifications specifically regarding viscosity. The record does not describe what this failure means for safety or efficacy, nor does it list any injuries associated with the defect.
Who’s affected
Patients who have been prescribed Alinia powder for oral suspension and possess the specific lot numbers listed in the record are affected. The recall applies to units distributed nationwide.
How to tell if you have this one
Look for Alinia (nitazoxanide) powder for oral suspension, 100mg/5mL, in 60 mL bottles. Check the lot numbers: MTEW1721 (Exp 09/2016), MTCW21281 (Exp 09/2016), MTCW21291 (Exp 09/2016), MTEW5791 (Exp 12/2016), and MTEW5801 (Exp 01/2017). The product is Rx only and manufactured for Lupin Pharmaceuticals Inc.
- Brand
Romark Laboratories- Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 18 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0983-2015 (April 24, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0983-2015 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.