Bausch & Lomb, Inc.

Complete recall history across all FDA and CPSC categories — 9 total recalls

Bausch & Lomb, Inc. appears in recall records across 2 categories. 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 (8)

FDA drug safety enforcement actions by Bausch & Lomb, Inc.

Date Product Reason Class
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 th... Class II
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 upda... Class III
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 upda... Class III
Jan 18, 2016 Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL... Labeling: Incorrect or Missing Package Insert: Package insert is missing upda... Class III
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
Apr 10, 2014 Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in... Crystallization: Crystal precipitate formation and an increase in the number ... Class II
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 ... Class II
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 Mu... Class II

Device Recalls (1)

FDA medical device enforcement actions by Bausch & Lomb, Inc.

Date Product Reason Class
Oct 12, 2016 Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic ... According to firm ( Bausch & Lomb, Inc. ) on June 17, 2016 a packaging opera... Class II

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.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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