Magnesium Sulfate Inj — Class I drug recall D-1137-2016
Ongoing recall by Hospira Inc., reported 2016-07-13, distributed nationwide. Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
| Recall number | D-1137-2016 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2016-03-23 |
| Classified | 2016-07-06 |
| Reported by FDA | 2016-07-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, BH, KW |
| Quantity | 88,500 vials |
| Reason classes | specification failure |
| NDC | 00409-2168-02 |
| Expiration dates | 2017-02-01 |
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
Presence of Particulate Matter: Confirmed customer complaint for the presence of particulate matter.
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-1137-2016. 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.