Class II · ModerateRecall completed
Pantoprazole Sodium Delayed-Release Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: PA217060A, Exp 05/2020
Where it was soldNationwide in the USA.
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
Discoloration: Expansion of an earlier recall due to the presence of dark brown discoloration on the edges of the tablets.
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 byJubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; foreign manufacturer
| Distributed by / for | Jubilant Cadista Pharmaceuticals, Inc. |
| NDC | 59746-284-90 |
Show the full FDA record
| Full product label | Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx Only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90. |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc. |
| Distribution | Nationwide in the USA. |
| Quantity | 12,960 bottles |
| Recall initiated | 2019-03-29 |
| Report date | 2019-04-10 |
| Recall completed | 2019-09-20 |
| Recall number | D-1074-2019 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Salisbury MD 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.