The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0147-2023·Announced 2023-01-25

Eye drop medication Olopatadine HCl recalled nationwide for manufacturing deviations

Akorn, Inc. is recalling 31,073 bottles of Olopatadine HCl ophthalmic solution nationwide due to current good manufacturing practice deviations. This voluntary recall was initiated by the manufacturer.

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: FDA Class II recall for manufacturing deviations in a pharmaceutical product. No illnesses or injuries have been reported. The score reflects potential risk from quality concerns in pharmaceutical manufacturing balanced against the absence of documented harm, fitting the rubric criterion of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Akorn, Inc. is recalling 31,073 bottles of Olopatadine HCl Ophthalmic Solution, USP 0.1% nationwide. The product is a prescription eye drop medication supplied in 5 mL dropper bottles.

The recall was initiated due to current good manufacturing practice (CGMP) deviations identified at the manufacturer's facility. This is a voluntary recall initiated by the firm.

The recalled lot is Lot 1B41A with an expiration date of January 31, 2023. The product was distributed nationwide in the United States.

Consumers with this product should consult with their healthcare provider or pharmacist regarding next steps. Do not use the product without medical guidance.

The recalled product

Product
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic Solution
Hazard
Affected units
31,073

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 (2)

  • Lot: Lot 1B41A
  • EXP 1/31/2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 27 recalled by Akorn, 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 27 products in this recall →

Related recalls

Same manufacturer · Akorn, Inc.

See all →

Same hazard · manufacturing defect

See all →

Similar recalls