The Recall Desk
HighFDA (Drugs)·D-0156-2023·Announced 2023-01-25

Eye-drop drug recall: Timolol solution due to manufacturing deviations

Akorn is recalling over 1.3 million bottles of Timolol Maleate eye drops distributed nationwide due to manufacturing process violations. The voluntary recall addresses risks from Current Good Manufacturing Practice deviations.

What this means for you

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 recalls indicate potential for serious adverse health consequences. Current Good Manufacturing Practice deviations represent a risk to product quality and safety in a sterile pharmaceutical, though no illnesses or injuries have been reported.

Plain-English summary

Akorn, Inc. is recalling Timolol Maleate Ophthalmic Solution, USP, 0.5%, a prescription eye drop medication. The recall affects over 1.3 million bottles distributed nationwide in the United States. The product is packaged in three sizes: 5 mL, 10 mL, and 15 mL dropper bottles.

The company initiated this voluntary recall due to Current Good Manufacturing Practice (CGMP) deviations identified at the manufacturing facility. CGMP regulations establish standards for how medications must be manufactured to ensure quality and safety.

Patients should contact their pharmacy or healthcare provider if they have bottles from recalled lot numbers. Do not stop taking medication without guidance from your healthcare provider. The recall status is ongoing.

The recalled product

Product
Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.
Manufacturer
Akorn, Inc.
Category
Drug — Ophthalmic / Eye Drops
Hazard
Affected units
1,310,324

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)

  • Lot: (a) 0B50A
  • 0B69A
  • EXP 1/31/2023
  • 0C74A
  • EXP 2/28/2023
  • 0D04A
  • EXP 3/31/2023
  • 0E37A
  • EXP 4/30/2023
  • 0G07A
  • 0G82A
  • EXP 6/30/2023
  • 0H26A
  • 0H28A
  • 0H53A
  • 0H36A
  • EXP 7/31/2023
  • 0J64A
  • 0J58A
  • 0J66A

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 →

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