EPSOM SALT — Class III drug recall D-0564-2016
Terminated recall by PQ Corporation, reported 2016-01-13, distributed in KY. Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it
| Recall number | D-0564-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | PQ Corporation, Utica, IL, United States |
| Recall initiated | 2015-10-29 |
| Classified | 2016-01-07 |
| Reported by FDA | 2016-01-13 |
| Terminated | 2016-12-21 |
| Distributed | KY |
| Reason classes | specification failure |
| Lot numbers | 05/18, U150511 |
Product
EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge, Pennsylvania USA 19482.
Reason for recall
Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).
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-0564-2016. 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.