Over 100 lots of losartan tablets recalled after NMBA detected

By Maggie Lynch

- Last updated on GMT

(Image: Getty/AndreaObzerova)
(Image: Getty/AndreaObzerova)

Related tags losartan Sartan Recall India Hetero Labs

Teva begins recall in the US of 35 lots of losartan tablets and Torrent expands its recall to include an additional 104 lots, after trace amounts of NMBA were discovered in both companies' products.

The recall from Torrent includes 36 lots of losartan potassium tablets and 68 lots of losartan potassium/hydrochlorothiazide tablets to the consumer level, after the possibly carcinogenic impurity N-Methylnitrosobutric acid (NMBA) was found in the tablets’ active pharmaceutical ingredient (API). Teva also initiated a recall of its losartan potassium tablets, 35 lots of the medicine, also due to the detection of NMBA in its API. 

Hetero Labs, a pharmaceutical manufacturing company based in Hyderabad, India, produced all 104 lots of API for Torrent Pharmaceuticals and Teva's medicine. 

NMBA was also recently found in the API of Legacy Pharmaceutical Packaging​ repackaged losartan tablets, after Camber Pharmaceuticals​ issued a voluntary nationwide recall of its losartan tablets.

Recently, sartan based products such as valsartan and losartan have been recalled due to the detection of impurities of NMBA, N-nitrosodiethylamine (NDEA), and N-nitrosodimenthyamine (NDMA).

To date, neither Teva nor Torrent have received any reports of adverse events related to this recall.

Investigations into the cause of the impurities in sartan products are underway from both the European Medicines Agency​ (EMA) and the US Food and Drug Administration (FDA). Most recently, the EMA stated it had drawn conclusions as to the cause and is working to find solutions to identify and avoid further contamination of sartan products.

Due to the frequent recalls of sartan products, the FDA prioritized a generic of valsartan​ from Alkem Laboratories in an attempt to alleviate any shortages that may occur.

Related news

Show more

Related products

A Guide Through the API Drug Development Pipeline.

A Guide Through the API Drug Development Pipeline.

Content provided by Lonza Small Molecules | 04-Apr-2023 | Insight Guide

With the complexities associated with API and HPAPI drug development, it’s necessary to lean on the experts. With Q&A sections, insights and articles...

Understanding the hidden value of quality

Understanding the hidden value of quality

Content provided by Thermo Fisher Scientific – Production Chemicals and Services | 16-Jan-2023 | White Paper

The raw material supply is too vital to leave to chance, and quality-related supply chain activities are cornerstones to your success.

Related suppliers

Follow us


View more