Agency classClass IIIOur severity:Low FDA (Drugs)·D-0646-2016·Announced 2016-02-03

Bausch & Lomb Recalls Tropicamide Ophthalmic Solution Due to Labeling Defect

Bausch & Lomb is recalling Tropicamide Ophthalmic Solution 0.5% 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 the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/labeling defect rather than a physical hazard.

Plain-English summary

Bausch & Lomb, Inc. is recalling Tropicamide Ophthalmic Solution USP, 0.5%, packaged in 15 mL bottles. The recall involves 119,393 bottles distributed nationwide in the U.S. and Puerto Rico. The specific lots affected include 199001, 222591, 224491, 229241, 232941, 239921, 241701, and 246851, with expiration dates ranging from January 2016 to July 2017.

The reason for the recall is a labeling issue where the package insert is missing updates compared with the reference drug insert. This is classified as an FDA Class III recall, indicating that the product is not likely to cause adverse health consequences or death.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the distributor or Bausch & Lomb, Inc. for credit or replacement.

The recalled product

Product: TROPICAMIDE (TROPICAMIDE)
Brand: TROPICAMIDE
Manufacturer: Bausch & Lomb, Inc.
Category: Drug — Ophthalmic Solution
Hazard: mis-labeling
Affected units: 119,393

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 (16)

Lot #:199001
Expiry: 01/2016
Lot #: 222591
Expiry: 04/2016
Lot #: 224491
Expiry: 06/2016
Lot #: 229241
Expiry: 08/2016
Lot #: 232941
Expiry: 11/2016
Lot #: 239921
Expiry: 02/2017
Lot #: 241701
Expiry: 04/2017
Lot #: 246851
Expiry: 07/2017.

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 Error
FDA (Drugs) · 2016-02-03

Same manufacturer · Bausch & Lomb, Inc.

See all →

High
Bausch + Lomb Stellaris Elite Vit Cutter Back Cap Separation Recall
FDA (Devices) · 2018-10-03
High
Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
FDA (Devices) · 2018-10-03
High
Bausch + Lomb Stellaris Elite Vit Cutter Recall for Back Cap Separation
FDA (Devices) · 2018-10-03
High
Bausch + Lomb Stellaris Elite Vit Cutter Recall for Cap Separation
FDA (Devices) · 2018-10-03
High
Bausch + Lomb Stellaris Elite Vit Cutter Recall Due to Cap Separation
FDA (Devices) · 2018-10-03

Same hazard · mis labeling