Morton Grove Pharmaceuticals, Inc.
Complete recall history across all FDA and CPSC categories — 9 total recalls
Morton Grove Pharmaceuticals, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (9)
FDA drug safety enforcement actions by Morton Grove Pharmaceuticals, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Feb 21, 2022 | Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only,... | Failed Impurities/Degradation Specifications: higher than permissible levels ... | Class II |
| Sep 3, 2021 | Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP... | CGMP Deviations: Potential concern with products manufactured using liquid su... | Class II |
| Sep 3, 2021 | Valproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, M... | CGMP Deviations: Potential concern with products manufactured using liquid su... | Class II |
| Sep 3, 2021 | Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/... | CGMP Deviations: Potential concern with products manufactured using liquid su... | Class II |
| Dec 9, 2020 | Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in... | Failed Impurities/Degradation Specification: OOS for the following - unknown ... | Class II |
| Sep 23, 2019 | Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl o... | Failed Impurities/Degradation Specifications - failed specs for Prednisolone ... | Class II |
| Jul 24, 2018 | Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, 8 fl oz (237 mL) Bot... | Defective Container: Tamper Evident foil seal not completely intact. | Class II |
| Aug 10, 2017 | Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg p... | Presence of Foreign Substance: customer complaint of blue foreign material id... | Class II |
| Dec 15, 2015 | Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottl... | Super-Potent Drug: Out of Specification Assay test results were reported for ... | Class III |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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