RecallRadar

FDA Drug recall D-0130-2020

Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharm…

On 2019-10-16 the FDA classified a Class II recall of Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove Pharm… by Morton Grove Pharmaceuticals, citing failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0130-2020
ClassificationClass II
Statusterminated
Initiated2019-09-23
Published2019-10-16
Last updated2026-09-13 11:52 UTC
CompanyMorton Grove Pharmaceuticals
DistributionUS

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

Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14

Identifiers

code_infoLot #: US1450, Exp 10/31/19; US1570, Exp 12/31/19; UT1018, Exp 1/31/19; UT1173, Exp 6/30/20; UT1348, UT1354, Exp 8/31/20

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0130-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.