Magnesium Sulfate Inj — Class III drug recall D-0854-2016
Ongoing recall by Hospira Inc., reported 2016-05-25, distributed nationwide. Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
| Recall number | D-0854-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2016-03-23 |
| Classified | 2016-05-16 |
| Reported by FDA | 2016-05-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BH, IL, KW, TT |
| Quantity | 715,200 vials |
| Reason classes | specification failure |
| NDC | 00409-2168-02 |
| Lot numbers | 42-335-DK, 48-128-DK, 48-129-DK, 48-261-DK, 48-262-DK, 48-351-DK, 52-361-DK |
| Expiration dates | 2016-06-01, 2016-12-01, 2017-04-01 |
Product
Magnesium Sulfate Inj., USP 50%, 10 g/20 mL (0.5 g/mL), (4 mEq Magnesium/mL, 20 mL Single-dose vial, packaged in 25 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2168-02, barcode (01) 2 030409 216802 5.
Reason for recall
Failed pH Specifications: Confirmed high out of specification (OOS) results for pH.
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-0854-2016. 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.