Class III · Lower riskRecall completed
Candesartan Cilexetil Tablets
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numbera) 3022288 12/2015 3025988 03/2016 3025989 04/2016 3030459 08/2016 3030460 08/2016 3032087 10/2016 3032088 10/2016 3034506 12/2016 3035952 01/2017 3035953 01/2017 b) 3022287 12/2015 3025990 04/2016 3030458 08/2016 3032086 09/2016 3035954 01/2017
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications; 9 month stability timepoint
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byMylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540 foreign manufacturer
| Distributed by / for | Sandoz Inc |
| NDC | 00781-5938-31 |
Show the full FDA record
| Full product label | Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540 |
| Recalling firm | Sandoz Inc |
| Distribution | Nationwide |
| Quantity | 277,267 bottles |
| Recall initiated | 2015-12-31 |
| Report date | 2016-02-17 |
| Recall completed | 2017-04-12 |
| Recall number | D-0659-2016 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.