Earache Drops — Class II drug recall D-0991-2022
Terminated recall by Grato Holdings, Inc., reported 2022-06-15, distributed nationwide. Microbial contamination of non-sterile product.
| Recall number | D-0991-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Grato Holdings, Inc., Woodbine, IA, United States |
| Recall initiated | 2022-05-24 |
| Classified | 2022-06-08 |
| Reported by FDA | 2022-06-15 |
| Terminated | 2023-06-08 |
| Distributed | Nationwide (US) |
| Quantity | 31,872 bottles |
| Reason classes | microbial contamination, sterility |
| NDC | 00363-3233, 00363-3233-15 |
| Lot numbers | 09/24, G11639 |
Product
Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15
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-0991-2022. 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.