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Browse Drug Recalls

21 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 21 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 21 FDA drug recalls.

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DateProductReasonClassFirm
Dec 18, 2025 Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection... Presence of particulate matter - Glass like particles. Class II Imprimis NJOF, LLC
Dec 18, 2025 Dexamethasone Moxifloxacin Ketorolac, 1 mg/mL, 0.5 mg/mL, 0.4 mg/mL) Single... Presence of particulate matter - Glass like particles. Class II Imprimis NJOF, LLC
Dec 18, 2025 Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use... Presence of particulate matter - Glass like particles. Class II Imprimis NJOF, LLC
Oct 20, 2025 Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emu... Subpotent Drug Class III Imprimis NJOF, LLC
Jul 9, 2025 Epinephrine Lidocaine HCL, 0.25mg/mL and 7.5 mg/mL, 20x1 mL Vials per carton,... Sub-Potent Drug: Subpotent assay results during stability testing. Class II Imprimis NJOF, LLC
Jul 9, 2025 Tropicamide-Proparacaine-Phenylephrine-Ketorolac, Sterile Ophthalmic Solution... Sub-Potent Drug: Subpotent assay results during stability testing. Class III Imprimis NJOF, LLC
Feb 24, 2025 Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile Ophthalmic Sol... Sub-Potent Drug: The stability batch showed a subpotent result, which does not meet the product s... Class III Imprimis NJOF, LLC
May 14, 2024 Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Sing... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
May 14, 2024 Klarity-C (cyclosporine) Preservative-Free Sterile Ophthalmic Emulsion 0.1% 5... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
May 14, 2024 Dexamethasone-Moxifloxacin (1 mg/mL and 5mg/mL) Preservative-Free, 1mL Single... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
May 14, 2024 Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free 1mL Sing... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
May 14, 2024 Moxifloxacin 0.8 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intra... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
May 14, 2024 Moxifloxacin 4 mg/0.8 mL Preservative-Free 0.8mL Single-Use vials for Intraoc... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
May 14, 2024 Dexamethasone-Moxifloxacin- Ketorolac (1mg/mL, 0.5 mg/mL and 0.4 mg/mL), Pres... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
May 14, 2024 Prednisolone-Moxifloxacin-Bromfenac Sterile Ophthalmic Suspension, 1%, 0.5%, ... Lack of Assurance of Sterility Class II Imprimis NJOF, LLC
Apr 10, 2024 Epinephrine-Lidocaine HCl 0.25 mg/mL and 7.5 mg/mL Preservative-Free, 1 mL S... Out of specification for assay Class III Imprimis NJOF, LLC
Apr 10, 2024 Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solut... Subpotent Drug Class II Imprimis NJOF, LLC
Oct 3, 2023 Epinephrine-Lidocaine HCl (0.25mg/mL and 7.5mg/mL) 1mL Single Use Intraocular... Subpotent: Failing Test Results for Epinephrine Class III Imprimis NJOF, LLC
Sep 20, 2023 MYDRIATIC-4: Tropicamide - Proparacaine - Phenylephrine - Ketorolac Sterile O... Subpotent: Out of Specification result observed for Ketorolac assay levels, below the 90.0-110.0%... Class III Imprimis NJOF, LLC
Aug 10, 2023 Moxifloxacin - Bromfenac Sterile Ophthalmic Solution 0.5% / 0.075%, 5mL bottl... Subpotent Drug; sub-potent Bromfenac levels, below the 90.0-110.0% specification range. Class III Imprimis NJOF, LLC
Dec 17, 2020 Dexamethasone - Moxifloxacin PF Injection (1/5) mg/mL, Imprimis Rx Volume: 1m... Lack of assurance of sterility: 13 vials were discovered to have faulty crimps. Class II Imprimis NJOF, LLC

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.