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Browse Drug Recalls

9 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 9 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 9 FDA drug recalls.

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DateProductReasonClassFirm
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 of unknown impuritie... Class II Morton Grove Pharmaceuticals, Inc.
Sep 3, 2021 Promethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP... CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin... Class II Morton Grove Pharmaceuticals, Inc.
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 sugar batches contamin... Class II Morton Grove Pharmaceuticals, Inc.
Sep 3, 2021 Promethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/... CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contamin... Class II Morton Grove Pharmaceuticals, Inc.
Dec 9, 2020 Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in... Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, ... Class II Morton Grove Pharmaceuticals, Inc.
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 Impurity 14 Class II Morton Grove Pharmaceuticals, Inc.
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 Morton Grove Pharmaceuticals, Inc.
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 identified as a portio... Class II Morton Grove Pharmaceuticals, Inc.
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 stability samples. Class III Morton Grove Pharmaceuticals, Inc.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.