Alinia Oral Suspension (Romark) – Stability Specification Failure (2015)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
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
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
Brand
Romark Laboratories, L.C.
Lot Codes / Batch Numbers
Lot #: MTEW1721, MTCW21281, MTCW21291, Exp 09/2016, Lot #: MTEW5791, Exp 12/2016, Lot #: MTEW5801, Exp 01/2017.
Products Sold
Lot #: MTEW1721, MTCW21281, MTCW21291, Exp 09/2016; Lot #: MTEW5791, Exp 12/2016; Lot #: MTEW5801, Exp 01/2017.
Romark Laboratories, L.C. is recalling Alinia (nitazoxanide), powder for oral suspension, 100mg/5mL, 60 mL/bottle. Rx only, Manufactured fo due to Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity. 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
Failed Stability Specifications: Product failed to meet 12 months long term stability specification for viscosity
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