Prednisolone Sodium Phosphate Oral Solution — Class II drug recall D-0130-2020
Terminated recall by Morton Grove Pharmaceuticals, Inc., reported 2019-10-16, distributed nationwide. Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
| Recall number | D-0130-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Morton Grove Pharmaceuticals, Inc., Morton Grove, IL, United States |
| Recall initiated | 2019-09-23 |
| Classified | 2019-10-08 |
| Reported by FDA | 2019-10-16 |
| Terminated | 2022-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 196,408 bottles |
| Reason classes | specification failure |
| NDC | 60432-0212-08 |
| Lot numbers | US1450, US1570, UT1018, UT1173, UT1348, UT1354 |
| Expiration dates | 2019-01-31, 2019-10-31, 2019-12-31, 2020-06-30, 2020-08-31 |
Product
Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053. NDC 60432-212-08
Reason for recall
Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14
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-0130-2020. 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.