Generic drug makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of WockhardtLabelled by claude-sonnet-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Morton Grove Pharmaceuticals with 22 drug applications and 9 drug recalls. The most recent is a drug recall dated Feb 21, 2022: Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactur….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Feb 21, 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 GrClass II · Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the dru | Drug recalls |
| Sep 3, 2021 | Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Class II · CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial org | Drug recalls |
| Sep 3, 2021 | Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; ManuClass II · CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial org | Drug recalls |
| Sep 3, 2021 | Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LClass II · CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial org | Drug recalls |
| Dec 9, 2020 | 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 mClass II · Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, an | Drug recalls |
| Sep 23, 2019 | Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl oz (237 mL) bottle, Rx only, Manufactured By Morton Grove PharmaClass II · Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14 | Drug recalls |
| Jul 24, 2018 | Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, IClass II · Defective Container: Tamper Evident foil seal not completely intact. | Drug recalls |
| Aug 10, 2017 | Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg per 5 mL, 100 mL (when reconstituted) bottle, Rx Only, ManufactuClass II · Presence of Foreign Substance: customer complaint of blue foreign material identified as a portion of a nitrile glove wa | Drug recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
