Dr — Class II drug recall D-0036-2024
Ongoing recall by Dr. Berne's Whole Health Products, reported 2023-10-11, distributed nationwide. CGMP Deviations
| Recall number | D-0036-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Berne's Whole Health Products, Tesuque, NM, United States |
| Recall initiated | 2023-08-26 |
| Classified | 2023-10-04 |
| Reported by FDA | 2023-10-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BB, BE, CA, CH, DE, FI, FR, GB, HK, IE, IL, IN, IT, KR, KW, LV, MT, NL, NO, PT, RO, SE, SG, SI, TH, ZA |
| Quantity | 3,833 bottles |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00854582001111 |
| Lot numbers | 02/25, 03/24, 03/25, 06/24, 07/25, 08/24, 09/24, 11/23, 11/24, 6485, 6562, 6624, 6669, 6688, 6727, 6771, 6830, 6887 |
Product
Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001111.
Reason for recall
CGMP Deviations
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-0036-2024. 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.