Zinc Sulfate — Class II drug recall D-0377-2016
Terminated recall by Downing Labs, LLC, reported 2015-11-25, distributed nationwide. Lack of Assurance of Sterility
| Recall number | D-0377-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Downing Labs, LLC, Dallas, TX, United States |
| Recall initiated | 2015-10-16 |
| Classified | 2015-11-18 |
| Reported by FDA | 2015-11-25 |
| Terminated | 2016-09-22 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, BS, CH, CO, FR, HK, ID, IN, JP, MY, NZ, SG, TH, TT, TW |
| Quantity | 74 vials |
| Reason classes | sterility |
Product
Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435
Reason for recall
Lack of Assurance of Sterility
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-0377-2016. 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.