Major Infants' Gas Relief Drops — Class II drug recall D-0126-2020
Terminated recall by GCP Laboratories Inc, reported 2019-10-16, distributed nationwide. Microbial Contamination of Non-Sterile Product.
| Recall number | D-0126-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GCP Laboratories Inc, Gulfport, MS, United States |
| Recall initiated | 2019-09-18 |
| Classified | 2019-10-07 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2021-02-05 |
| Distributed | Nationwide (US) |
| Quantity | 31,392 |
| Reason classes | microbial contamination, sterility |
| NDC | 00904-5894-30 |
| Lot numbers | 03/21, WBD003 |
Product
Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30 mL) bottle, Distributed by: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152 USA. NDC 0904-5894-30
Reason for recall
Microbial Contamination of Non-Sterile Product.
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-0126-2020. 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.