Referring to the widespread recalls of blood pressure medications — specifically valsartan, losartan, and irbesartan — that began in 2018 and continued for several years. These are all ARBs (angiotensin II receptor blockers) used to treat high blood pressure and heart failure.
What caused the recalls
The contamination involved nitrosamine impurities — specifically:
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NDMA (N-nitrosodimethylamine)
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NDEA (N-nitrosodiethylamine)
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NMBA (N-nitrosomethylaminobutyric acid)
These are classified as probable human carcinogens based on animal studies. They were found in the active pharmaceutical ingredient (API) — valsartan and others — manufactured primarily by Chinese and Indian API suppliers, notably Zhejiang Huahai Pharmaceutical and Hetero Labs.
Why it happened
The impurities formed due to changes in manufacturing processes at the API plants. In some cases, solvents and reagents used in production reacted to form nitrosamines. The FDA and EMA later determined that some of these process changes had not been properly reported or reviewed.
Scope of the recall
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Dozens of generic versions of valsartan, losartan, and irbesartan were recalled worldwide
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Manufacturers included Teva, Mylan, Sandoz, Aurobindo, Torrent, Hetero, and others
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The recalls affected thousands of lots and multiple countries
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It’s considered one of the largest pharmaceutical recall events in recent history
Health risk
The risk to any individual patient was generally considered low — the impurities were present at relatively low levels, and the cancer risk from short-term exposure is small. However, because these are lifelong medications for many patients, the concern was cumulative exposure over years or decades.
What patients were advised
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Do not stop taking your medication without talking to your doctor — the risk from untreated high blood pressure is immediate and serious
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Pharmacists and doctors worked to switch patients to unaffected lots or alternative medications
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The FDA maintained a list of recalled products and safe alternatives
Aftermath and reforms
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The FDA and EMA tightened API manufacturing oversight
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New testing methods were developed to detect nitrosamines at very low levels
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This eventually led to additional recalls of other drugs — notably ranitidine (Zantac) in 2020 and metformin in 2020–2021 — due to the same class of impurities
If you’re asking about a specific recent recall or a particular manufacturer, let me know and I can look into that.