Fast Acting Earwax Removal System — Class II drug recall D-0537-2023
Ongoing recall by Pharma Nobis LLC, reported 2023-04-26, distributed nationwide. CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
| Recall number | D-0537-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Pharma Nobis LLC, Texarkana, TX, United States |
| Recall initiated | 2023-04-06 |
| Classified | 2023-04-14 |
| Reported by FDA | 2023-04-26 |
| Distributed | Nationwide (US) |
| Quantity | 69,615 bottles |
| Reason classes | labeling, potency, cgmp, specification failure |
| UPC / GTIN / UDI-DI | 00050428364758 |
| Lot numbers | A70293, A70294, A70295, A70746, A70747, A70748, A70749, A73051, A73052 |
| Expiration dates | 2023-12, 2024-01, 2024-05 |
Product
Fast Acting Earwax Removal System (carbamide peroxide), 6.5%, 0.5 FL OZ (15 mL) Drops per bottle, OTC, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, CVS Product # 999532, UPC 0 50428 36475 8.
Reason for recall
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
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-0537-2023. 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.