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 # PA218005A, exp. date 12/2020, PA218P010, PA218P011, exp. date 04/2021, PA218108A, PA218110A, exp. date 06/2021
Where it was soldDistributed Nationwide 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
CGMP Deviations: Presence of dark brown discoloration on edges of 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 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, NDC 59746-284-90 |
| Recalling firm | Jubilant Cadista Pharmaceuticals, Inc. |
| Distribution | Distributed Nationwide in the USA |
| Quantity | 89,376 90-count bottles |
| Recall initiated | 2020-03-11 |
| Report date | 2020-03-25 |
| Recall completed | 2020-06-10 |
| Recall number | D-1058-2020 |
| 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.