Little Remedies Gas Relief Drops — Class II drug recall D-0557-2024
Terminated recall by Denison Pharmaceuticals, LLC, reported 2024-06-26. cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
| Recall number | D-0557-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Denison Pharmaceuticals, LLC, Lincoln, RI, United States |
| Recall initiated | 2024-05-28 |
| Classified | 2024-06-17 |
| Reported by FDA | 2024-06-26 |
| Terminated | 2025-08-26 |
| Quantity | 113,544 bottles |
| Reason classes | cgmp |
| Pathogens | burkholderia |
| NDC | 63029-0103, 63029-0103-01, 63029-0103-02 |
| Lot numbers | 0855, 2025, 8/31 |
Product
Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02
Reason for recall
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
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-0557-2024. 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.