Bausch & Lomb Inc

FDA recalling firm · 9 enforcement events · 26 product records · 2011–2018 · FL, MO

Bausch & Lomb Inc has 9 FDA enforcement events on this register (26 product records) between 2011 and 2018: 5 drug and 4 device; the busiest year was 2014 with 2.

0% of its events are Class I; the most common class is Class II (8). 0 events are listed as ongoing; the recalling firm's address is in FL and MO.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
8 Aug 2018	Bausch + Lomb Stellaris Elite 20 GA Vit Cutter, Model BL5626, 7500 cpm, packaged in sterile pouches, 6/shipper.	Device	Class II	13	Terminated
6 Jun 2017	NasalCrom (cromolyn sodium) Nasal Spray, USP, 5.2 mg per spray, 200 metered sprays, 0.88 FL OZ (26 mL) metered spray pump bottle, Distributed by: Medtech Products, Inc., Tarrytown, NY 10591, UPC 8 148332 01101 7.	Drug	Class II	1	Terminated
12 Oct 2016	Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies from the eye of the patient	Device	Class II	1	Terminated
18 Jan 2016	Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.	Drug	Class III	3	Terminated
17 Aug 2015	Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637. NDC: 24208-439-01.	Drug	Class II	1	Terminated
4 Nov 2014	Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY	Device	Class II	3	Terminated
10 Apr 2014	Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sample, NDC 24208-385-01, UPC 3 24208-385-01 2; b) 1/8 oz. (3.5 g) tube per carton, NDC 24208-385-55, UPC 3 24208-385-55 5; and c) 1/4 oz. (7 g) Twin Pack, Two 1/8 oz. (3.5 g) tubes per carton, NDC…	Drug	Class II	2	Terminated
31 Aug 2012	Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the emulsification and removal of cataracts, anterior, and posterior segment vitrectomy.	Device	Class II	1	Terminated
6 Jul 2011	Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incorporated, Tampa, FL 33637, NDC 24208-280-15	Drug	Class II	1	Terminated

By type and class

Drug5

Device4

Class II8

Class III1

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Bausch & Lomb Inc by year initiated.

Questions and answers

How many FDA recalls has Bausch & Lomb Inc had?

9 enforcement events (26 product records) on this register, 2011–2018: 5 drug, 4 device.

Are any Bausch & Lomb Inc recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Bausch & Lomb Inc recalls?

8 Class II, 1 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.