Lupin and Granules India, two leading pharmaceutical exporters from India, will be recalling 9.71 lakh bottles of its generic diabetes drug in the US. It is reported that this could be because the lot contains the cancer causing NDMA above the acceptable intake limit. Lupin alone will recall 4.93 lakh bottles of Metformin Hydrochloride of 500 mg and 1000 mg.

Hyderabad-based Granules India will be recalling close to 4.78 lakh bottles of the drug of 750 mg. The FDA had detected NDMA impurity above the acceptable intake level. FDA has classified as a Class-II recall, indicating the product may cause temporary or medically reversible adverse health consequences.

The Metformin Hydrochloride extended-release tablet is an oral medication given as an adjunct to diet and exercise to improve blood glucose control in adults with type-2 diabetes mellitus. This problem has been faced by other global companies too. NDMA is classified as a probable human carcinogen. The impact of this recall is likely to be limited.