The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0461-2020·Announced 2019-11-27

DICLOFENAC Sodium Ophthalmic Solution Recalled Due to Lack of Sterility Assurance

Altaire Pharmaceuticals' diclofenac ophthalmic solution was recalled nationwide because sterility assurance cannot be assured.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a human prescription drug with a sterility assurance issue and no reported illnesses. Per the rubric, products with risk-of-harm where injury has not yet been reported fall under High severity (score 3).

Plain-English summary

The product being recalled is Altaire Diclofenac Sodium Ophthalmic Solution (0.1%, 5 mL), a human prescription drug manufactured by Altaire Pharmaceuticals, Inc., distributed nationwide across the United States. The recall is initiated because the product lacks assurance of sterility, meaning it may not meet required sterile preparation standards and could pose an infection risk if used. Consumers are advised not to use this product until further notice. The manufacturer, Altaire Pharmaceuticals, Inc., is responsible for addressing the issue and ensuring future batches comply with sterility requirements.

According to the recall notice, the root cause is a lack of assurance of sterility, which represents a potential harm pathway for patients using this ophthalmic solution. While no illnesses or injuries have been reported to date, the absence of sterility assurance places this product in a risk-of-harm category where injury has not yet been documented.

The product quantity involved in this recall is 49,527 units. The recall affects all units distributed nationwide under recall number D-0461-2020. Consumers should discontinue use immediately and seek medical attention if they experience any adverse effects. The manufacturer will work to resolve the sterility assurance issue and provide updated information through official channels.

The recalled product

Product
DICLOFENAC (DICLOFENAC SODIUM)
Brand
DICLOFENAC
Manufacturer
Altaire Pharmaceuticals, Inc.
Category
Drug — Human Prescription Drug
Hazard
Affected units
49,527

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)

  • 17225 07/19 17247 08/19 18038 02/20 18162 06/20 19014 01/21

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 134 recalled by Altaire Pharmaceuticals, 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 134 products in this recall →

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