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…
- FDA Drug
- Class II
- terminated
- Published 2022-03-09
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
| Agency | FDA Drug |
|---|---|
| Recall number | D-0713-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-21 |
| Published | 2022-03-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Morton Grove Pharmaceuticals |
| Distribution | US |
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_info | Lot #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.
Other recalls by Morton Grove Pharmaceuticals
- Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only,…
FDA Drug · Class II · 2021-09-29 · Morton Grove Pharmaceuticals - Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA,…
FDA Drug · Class II · 2021-09-29 · Morton Grove Pharmaceuticals - Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054
FDA Drug · Class II · 2021-09-29 · Morton Grove Pharmaceuticals - Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473…
FDA Drug · Class II · 2020-12-30 · Morton Grove Pharmaceuticals - 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…
FDA Drug · Class II · 2019-10-16 · Morton Grove Pharmaceuticals
All Morton Grove Pharmaceuticals recalls
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.