FDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
AbbVie Inc. is recalling 2,736 bottles of PRED MILD prednisolone acetate ophthalmic suspension (0.12%) due to failed stability specifications. The affected lots do not meet established stability standards and were distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This recall is classified as Moderate (FDA Class III) because while the product failed stability specifications, no illnesses or injuries have been reported. Class III recalls are the lowest regulatory category, typically used for situations where the likelihood of harm is remote.
Plain-English summary
AbbVie Inc. is recalling 2,736 bottles of PRED MILD (prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL) sold in the United States. The recalled product is a prescription eye drop medication.
The recall is being conducted because certain lots failed stability specifications. This means the product does not meet the required chemical and physical stability standards established during manufacturing quality assurance.
Affected lots are #402805 and #407596, with an expiration date of August 2026. The product was distributed nationwide. Patients currently using PRED MILD from these lots should contact their healthcare provider or pharmacist to discuss their treatment options and obtain an alternative product if needed.
The recalled product
- Product
- PRED MILD (PREDNISOLONE ACETATE)
- Brand
- PRED MILD
- Manufacturer
- AbbVie Inc.
- Category
- Drug — Ophthalmic
- Hazard
- stability-failure
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 (3)
- Lot # 402805
- 407596
- Exp Date: 08/2026.
UPCs (1)
- 0311980174101
Distribution
Distributed nationwide across the United States.
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