Agency classClass IIIOur severity:Low FDA (Drugs)·D-0647-2016·Announced 2016-02-03

Bausch & Lomb Recalls Tropicamide Ophthalmic Solution Due to Labeling Error

Bausch & Lomb is recalling Tropicamide Ophthalmic Solution because the package insert is missing updates compared to the reference drug insert.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a minor labeling error regarding missing updates in the package insert.

Plain-English summary

Bausch & Lomb, Inc. is recalling Tropicamide Ophthalmic Solution USP, 1%, packaged in 2 mL and 15 mL bottles. The recall is due to a labeling issue where the package insert is missing updates compared with the reference drug insert.

The affected product is a prescription-only ophthalmic solution distributed nationwide in the U.S., including Puerto Rico. The recall covers specific lots of both 2 mL and 15 mL bottles, with quantities totaling over 1 million units.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If the product is found, it should be returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatments if necessary.

The recalled product

Product: TROPICAMIDE (TROPICAMIDE)
Brand: TROPICAMIDE
Manufacturer: Bausch & Lomb, Inc.
Category: Drug — Ophthalmic Solution
Hazard: mis-labeling

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

a) Lot #: 232601
Expiry: 01/2016
Lot #: 233471
Expiry: 02/2016
Lot #: 234901
Expiry: 03/2016
Lot #: 238861
Expiry: 04/2016
Lot #: 239781
Lot #: 243351
Expiry: 08/2016
Lot #: 244931
Expiry: 09/2016. b) Lot #: 198821
Lot #: 198901
Lot #: 199961
Lot #: 220111
Lot #: 222281
Lot #: 222291
Lot #: 224841
Expiry: 06/2016

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Bausch & Lomb, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same brand · TROPICAMIDE

Low
Bausch & Lomb Recalls Tropicamide Ophthalmic Solution Due to Labeling Defect
FDA (Drugs) · 2016-02-03

Same manufacturer · Bausch & Lomb, Inc.

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Same hazard · mis labeling