Class II · ModerateActive recall
Aurobindo Ranitidine Caspules 150 mg
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberRA1518001-A Jul 2020 RA1518002-A Jul 2020 RA1518005-B Aug 2020 RA1518006-A Aug 2020 RA1519003-A May 2021
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
CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.
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
| Distributed by / for | Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 |
| NDC | 59651-144-60 |
Show the full FDA record
| Full product label | Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60 |
| Recalling firm | AuroMedics Pharma LLC |
| Distribution | nationwide |
| Quantity | 45,456 bottles |
| Recall initiated | 2019-11-06 |
| Report date | 2019-12-04 |
| Recall completed | — |
| Recall number | D-0527-2020 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | East Windsor 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.