RecallRadar

FDA Drug recall D-0713-2022

Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton G…

On 2022-03-09 the FDA classified a Class II recall of Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton G… by Morton Grove Pharmaceuticals, citing failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0713-2022
ClassificationClass II
Statusterminated
Initiated2022-02-21
Published2022-03-09
Last updated2026-09-13 11:52 UTC
CompanyMorton Grove Pharmaceuticals
DistributionUS

Product

Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053, NDC 60432-466-08.

Reason

Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.

Identifiers

code_infoLot #s: UV1004, UV1005, Exp 6/22; UW1014, UW1015, Exp 1/23; UW1084, Exp 7/23

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-0713-2022%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.