Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class III · Low risk Terminated Initiated Dec 26, 2019 (7 years ago)

Proparacaine Hydrochloride Ophthalmic Solution

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample

Cause type: Chemical / undeclared

A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.

What was recalled

Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-263-12

Affected NDC 17478-0263-12

Compare with the code on your package — it is the most precise check available.

Drug: Proparacaine Category: Eye Drops & Ophthalmic

Recalling firm
Akorn, Inc.
NDC code
17478-263-12
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1388-2020 · FDA notice

Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

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All 2019 recalls