Imipramine Pamoate Capsules 125 mg — Class II drug recall D-0027-2022
Terminated recall by Lupin Pharmaceuticals Inc., reported 2021-10-27, distributed nationwide. Out of specification result observed in a dissolution test at the 9-month long term stability time point.
| Recall number | D-0027-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2021-10-08 |
| Classified | 2021-10-22 |
| Reported by FDA | 2021-10-27 |
| Terminated | 2023-03-13 |
| Distributed | Nationwide (US) |
| Quantity | 1,902 bottles |
| Reason classes | specification failure |
| NDC | 68180-0314, 68180-0314-01, 68180-0314-06, 68180-0315, 68180-0315-01, 68180-0315-06, 68180-0316, 68180-0316-01, 68180-0316-06, 68180-0317, 68180-0317-01, 68180-0317-06 |
| Lot numbers | H002205 |
| Expiration dates | 2023-08 |
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 for recall
Out of specification result observed in a dissolution test at the 9-month long term stability time point.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0027-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.