Colic Calm — Class II drug recall D-0773-2023
Ongoing recall by Denison Pharmaceuticals, LLC, reported 2023-06-07, distributed nationwide. CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
| Recall number | D-0773-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Denison Pharmaceuticals, LLC, Lincoln, RI, United States |
| Recall initiated | 2023-05-03 |
| Classified | 2023-05-31 |
| Reported by FDA | 2023-06-07 |
| Distributed | Nationwide (US) |
| Quantity | 54,222 bottles |
| Reason classes | cgmp |
| Lot numbers | 8290V |
| Expiration dates | 2023-10 |
Product
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
Reason for recall
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
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-0773-2023. 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.