FDA Recall
Why Zantac Was Recalled
FDA recall timeline and NDMA contamination.
FDA Recall Statement
"FDA requested that all manufacturers withdraw their ranitidine products from the market because NDMA levels increase over time when stored at higher than room temperature, which may result in consumer exposure to unacceptable levels of this impurity."
Recall Timeline
1
September 2019
Valisure laboratory detects high NDMA levels in ranitidine
2
September 2019
FDA announces investigation into NDMA in ranitidine
3
October 2019
Major manufacturers issue voluntary recalls
4
April 2020
FDA requests withdrawal of ALL ranitidine products from U.S. market
5
2020-Present
Thousands of lawsuits filed against manufacturers
Key Discovery
- • NDMA forms when ranitidine is exposed to heat (even body temperature)
- • NDMA levels increase the longer ranitidine is stored
- • Testing showed some pills exceeded safe limits by thousands of times
- • All brand-name and generic ranitidine products were affected