PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only… recall
FDA recall D-0551-2026 · initiated May 18, 2026
AbbVie Inc. recalled PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Steril… in May 2026 — an FDA Class III recall (D-0551-2026) because Failed Stability Specifications.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Stability Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,736 bottles
Details
- Product
- PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product of France, NDC 11980-174-10.
- Recalling company
- Abbvie Inc
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- May 18, 2026
- FDA report date
- Jun 3, 2026
This recall is linked to a product we cover: Pred Mild →
Frequently asked
- Was PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Steril… recalled?
- AbbVie Inc. recalled PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Steril… in May 2026 — an FDA Class III recall (D-0551-2026) because Failed Stability Specifications. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Steril… recalled?
- Per the FDA enforcement record, the reason for recall D-0551-2026 was: Failed Stability Specifications
- Is a recalled PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Steril… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Steril… are affected?
- Distributed: US Nationwide.. The recall covers these lots — Lot # 402805, 407596, Exp Date: 08/2026.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0551-2026.