Lupin Pharmaceuticals is recalling 18,408 bottles of an antibiotic from the U.S. market.
The drugmaker said the recall of cefdinir for oral suspension was due to a report of a metal piece found in the product bottle.
The FDA has classified the recall as a Class 2, which is issued when the use or exposure to the drug may cause adverse events.
Cefdinir for oral suspension is manufactured by Lupin's manufacturing facility in central India. The affected lot is F802335 and is packaged in 60-milliliter bottles.