FDA Drug recall D-0027-2022
Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2021-10-27
On 2021-10-27 the FDA classified a Class II recall of Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc by Lupin Pharmaceuticals, citing out of specification result observed in a dissolution test at the 9-month long term stability time point.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0027-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-08 |
| Published | 2021-10-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Lupin Pharmaceuticals |
| Distribution | US |
Product
Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 454 775 India NDC# 68180-316-06
Reason
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Identifiers
| ndc | 68180-314-06 |
|---|---|
| ndc | 68180-314-01 |
| ndc | 68180-315-06 |
| ndc | 68180-315-01 |
| ndc | 68180-316-06 |
| ndc | 68180-316-01 |
| ndc | 68180-317-06 |
| ndc | 68180-317-01 |
| code_info | lot H002205, exp. date 08/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0027-2022%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.