LOPERAMIDE HCL TABLETS USP — Class III drug recall D-0391-2019
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2019-01-30, distributed in OH. Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 ca
| Recall number | D-0391-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2018-12-26 |
| Classified | 2019-01-23 |
| Reported by FDA | 2019-01-30 |
| Terminated | 2020-04-02 |
| Distributed | OH |
| Quantity | 5,040 cartons |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00093351112706 |
| NDC | 53943-0123, 53943-0123-12, 53943-0123-24 |
| Lot numbers | 2979325 |
Product
LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC, Distributed by Drug Mart-Food Fair Medina Ohio 44256 Ohm Laboratories Inc. UPC 0 93351 11270 6 NDC#:53943-123-24
Reason for recall
Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel indicates 12 caplets. The drug product carton contains 24 caplets.
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-0391-2019. 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.