ImprimisRx Povidone Iodine Ophthalmic Solution Recall Over Subpotent Drug
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
ImprimisRx NJ LLC is recalling 772 bottles of Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution due to subpotency.
FDA recall: what the record actually shows
This notice was issued by FDA on September 22, 2026 and geographically references United States. The FDA classifies this as a Class III recall, with the stated reason "Subpotent Drug", distributed usa nationwide. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Before acting, the primary agency source is available to check alongside this summary. Its related labels are recall, product-safety, fda, Drugs.
What Happened
ImprimisRx NJ LLC initiated a voluntary recall of the affected product because it is subpotent.
Which Products Are Affected
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, NDC 71384-732-10. Affected lots are 26JAN035 (BUD 09/07/2026) and 26FEB015 (BUD 09/24/2026). A total of 772 bottles were distributed nationwide in the United States.
What You Should Do
Consumers should contact the recalling firm for further information regarding the recall.
Why This Matters
This is a Class III recall involving a subpotent ophthalmic drug distributed across the United States.
Source
FDA Recall Number D-0835-2026
Original source: FDA Official Notice ↗
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Comparable nationwide notices (length or severity timing) 8
Beyond this FDA recall's own category, Areazine surfaces two nationwide peer sets: length-matched and severity/date-matched notices from elsewhere in the archive, distinct from the same-feed Related list above.
Similar body length
Nearest notices by article body length (702 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to September 22, 2026.
Common Questions
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