Drug & Device Safety Atlas

FDA drug recalls · openFDA

Is FLUORESCEIN SODIUM recalled?

The FDA has recorded 3 recalls of FLUORESCEIN SODIUM (2024–2025) , recalled under brands like C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS, GLOSTRIPS. 3 still ongoing.

0
Class I (most serious)
3
Class II
0
Class III
3
ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of FLUORESCEIN SODIUM ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not bein 2
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing pract 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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