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Browse Drug Recalls

11 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 11 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 11 FDA drug recalls.

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DateProductReasonClassFirm
Sep 11, 2024 Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5% (sterile), 15 mL bot... Temperature abuse: Products exposed to improper temperature above drug label specifications. Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Miocol-E (acetylcholine chloride intraocular solution) 20 mg/2mL (10 mg/mL), ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Jun 17, 2019 Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g bo... Failed Stability Specifications: Out of specification for viscosity. Class III Bausch & Lomb
Jun 6, 2017 NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered s... CGMP Deviations: Possibility of the presence of microbial contamination in the water used to manu... Class II Bausch & Lomb, Inc.
Jan 18, 2016 Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24... Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with re... Class III Bausch & Lomb, Inc.
Jan 18, 2016 Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only... Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with re... Class III Bausch & Lomb, Inc.
Jan 18, 2016 Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL... Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with re... Class III Bausch & Lomb, Inc.
Aug 17, 2015 Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured b... Lack of Assurance of Sterility: Failed preservative effectiveness testing. Class II Bausch & Lomb, Inc.
Apr 10, 2014 Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in... Crystallization: Crystal precipitate formation and an increase in the number of complaints associ... Class II Bausch & Lomb, Inc.
Apr 10, 2014 Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%, 1/8 oz. (3.5 g) tube p... Crystallization: Crystal precipitate formation and an increase in the number of complaints associ... Class II Bausch & Lomb, Inc.
Jul 6, 2011 Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottl... Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulos... Class II Bausch & Lomb, 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.