Food, drugs, devices › Bausch & Lomb, Inc.

Drug recall: Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL B

FDA enforcement event 73032 · Class III · initiated 18 Jan 2016 · status Terminated · terminated 6 Jan 2020

DrugVoluntary: Firm initiated3 product recordsTampa, FL

Bausch & Lomb, Inc. (Tampa, FL) initiated this drug recall on 18 Jan 2016; FDA lists 3 product records under event 73032, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 43% of the 288 drug enforcement events initiated in 2016 carry the same class.

Status: Terminated, terminated 6 Jan 2020. Initiation: voluntary: firm initiated. Bausch & Lomb, Inc. has 9 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

Bausch & Lomb, Inc., Tampa, FL.

Reason for recall

"Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert."

Distribution

"U.S. Nationwide including Puerto Rico."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0645-2016	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.	a) 905,956 Bottles, b) 191,375 Bottles	Class III	Terminated	3 Feb 2016
D-0646-2016	Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.	119,393 Bottles	Class III	Terminated	3 Feb 2016
D-0647-2016	Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.	a) 416,441 Bottles b) 674,177 Bottles	Class III	Terminated	3 Feb 2016

Context

43%of 2016 drug events are Class III288 events that year

3product records in this eventfirm median: 1

9events on this register for the firm

Other enforcement events for Bausch & Lomb, Inc.

Initiated	Product (first record)	Type	Class	Records
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
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 pum	Drug	Class II	1
12 Oct 2016	Algerbrush-II Product Usage: Medical - For surgeons to use in ophthalmic surgical procedures to remove foreign bodies fr	Device	Class II	1
17 Aug 2015	Bromfenac Ophthalmic Solution, 0.09%, 1.7 mL Bottle, Rx Only. Manufactured by Bausch & Lomb Incorporated Tampa, FL 33637	Drug	Class II	1
4 Nov 2014	Bausch & Lomb Stellaris PC w/ Laser, BL14304 The responsible firm name is Bausch & Lomb Incorporated Rochester, NY	Device	Class II	3
10 Apr 2014	Muro 128 (sodium chloride) hypertonicity ophthalmic ointment, 5%, packaged in a) 1 g tube per carton, professional sampl	Drug	Class II	2
31 Aug 2012	Bausch + Lomb Stellaris PC Vision Enhancement System, Posterior Fluidics Module (PFM). The system is intended for the em	Device	Class II	1
6 Jul 2011	Murocel (methylcellulose) Lubricant Opthalmic Solution (USP, 1%), 15 mL bottle, OTC, Manufactured by Bausch & Lomb Incor	Drug	Class II	1

All 9 events for Bausch & Lomb, Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "U.S. Nationwide including Puerto Rico."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 6 Jan 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.