FDA Drug recall D-0852-2022
Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Ind…
- FDA Drug
- Class II
- terminated
- Published 2022-05-11
On 2022-05-11 the FDA classified a Class II recall of Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Ind… by Torrent Pharma, citing CGMP deviations: tablets cracking.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0852-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-04-11 |
| Published | 2022-05-11 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Torrent Pharma |
| Distribution | US |
Product
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.
Reason
CGMP deviations: tablets cracking
Identifiers
| ndc | 13668-096-90 |
|---|---|
| ndc | 13668-429-30 |
| ndc | 13668-429-05 |
| ndc | 13668-429-90 |
| ndc | 13668-429-10 |
| code_info | Lot #s: BA34G021, BA34G022, Exp. 09/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Torrent Pharma
- Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA
FDA Drug · Class II · 2025-06-11 · Torrent Pharma - Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA
FDA Drug · Class II · 2025-06-11 · Torrent Pharma - Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd
FDA Drug · Class II · 2022-01-19 · Torrent Pharma - Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD.,…
FDA Drug · Class III · 2021-12-22 · Torrent Pharma - Anagrelide Capsules, USP 1 mg, 100 capsules, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ridge, NJ 07920 NDC 13668-462…
FDA Drug · Class I · 2020-12-09 · Torrent Pharma
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0852-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.