The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-0078-2018·Announced 2017-11-22

Allergan Recalls Lumigan Bimatoprost Ophthalmic Solution Due to Impurities

Allergan is recalling 153,616 bottles of Lumigan (bimatoprost) 0.01% ophthalmic solution because the product failed impurities and degradation specifications.

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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification failures without reported harm.

Plain-English summary

Allergan Sales, LLC is recalling 153,616 bottles of Lumigan (bimatoprost ophthalmic solution) 0.01%, 2.5 mL bottles. The recall is due to the product failing impurities and degradation specifications. The affected product is identified by Lot # 92575 with an expiration date of JUN-2018 and NDC# 0023-3205-03.

The recalled product was distributed nationwide and in Barbados, Curacao, Dominican Republic, Guyana, Jamaica, and Trinidad and Tobago. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers and healthcare providers should stop using the affected product and return it to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
LUMIGAN (BIMATOPROST)
Brand
LUMIGAN
Manufacturer
Allergan Sales, LLC
Category
Drug — Ophthalmic Solution
Hazard
Affected units
153,616

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 (1)

  • Lot #: 92575 Exp. JUN-2018

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Allergan Sales, LLC 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 2 products in this recall →

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