Class II · ModerateRecall completed
Pantoprazole Sodium
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #s: BA34G021, BA34G022, Exp. 09/2022
Where it was soldNationwide in the U.S.A
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: tablets cracking
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 byTorrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057 foreign manufacturer
| Brand name | PANTOPRAZOLE SODIUM |
| Generic name | PANTOPRAZOLE SODIUM |
| Active ingredient(s) | PANTOPRAZOLE SODIUM |
| Distributed by / for | Torrent Pharma Inc., Levittown, PA 19057 |
| NDC | 13668-096-90 |
Show the full FDA record
| Full product label | Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90. |
| Recalling firm | Torrent Pharma Inc |
| Distribution | Nationwide in the U.S.A |
| Quantity | 24,888 bottles |
| Recall initiated | 2022-04-11 |
| Report date | 2022-05-11 |
| Recall completed | 2023-07-25 |
| Recall number | D-0852-2022 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Levittown PA 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.