CLASS II Drug recall · Reported 13 May 2015 · FDA Enforcement Report
Alinia (nitazoxanide), powder for oral suspension, 100mg recalled
Romark Laboratories L.C is recalling Alinia (nitazoxanide), powder for oral suspension, 100mg, distributed nationwide in the US. The recall was initiated on 24 Apr 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0983-2015
- FDA event ID
- 70914
- Recalling firm
- Romark Laboratories L.C, Tampa, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2015
- FDA classified
- 4 May 2015
- Reported
- 13 May 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 24 Apr 2015 | Recall initiated by company | |
| 4 May 2015 | Classified by FDA | +10 days |
| 13 May 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured for Lupin Pharmaceuticals Inc, Baltimore, Maryland 21202 for Romark Laboratories 3000 Bayport Dr. Suite 200, Tampa, FL 33607
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
Which lots are affected?
Lot #: MTEW1721, MTCW21281, MTCW21291, Exp 09/2016; Lot #: MTEW5791, Exp 12/2016; Lot #: MTEW5801, Exp 01/2017.
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.