PRED MILD Ophthalmic Suspension Recall Issued

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

AbbVie Inc. is recalling 2,736 bottles of PRED MILD prednisolone acetate ophthalmic suspension due to failed stability specifications.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on June 23, 2026 and geographically references United States. Its severity classification of "low" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

AbbVie Inc. initiated a voluntary recall of PRED MILD after the product failed stability specifications.

Which Products Are Affected

PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only (NDC 11980-174-10). Affected lots are #402805 and #407596 with expiration date 08/2026. A total of 2,736 bottles distributed nationwide.

What You Should Do

Consumers should contact their prescribing physician or pharmacist regarding affected product.

Why This Matters

The recall affects a prescription ophthalmic drug distributed across the United States.

Source

FDA recall number D-0551-2026

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
AbbVie Inc. is recalling 2,736 bottles of PRED MILD prednisolone acetate ophthalmic suspension due to failed stability specifications.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "low" severity. No immediate action required, but stay aware.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.