Prednisolone Acetate Recall: Allergen Pred Mild
Announced 2026-06-03 · FDA
The FDA is recalling Prednisolone Acetate ophthalmic suspension (Pred Mild) due to failed stability specifications. About 2,736 bottles were distributed nationwide. Lot numbers 402805 and 407596 with expiration 08/2026 are affected; no corrective action details are provided.
| Brand | AbbVie Inc. |
|---|---|
| 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. |
| Reason | Failed Stability Specifications |
| Severity | low |
| Units affected | 2736 |
| Distribution | US Nationwide. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Check if you have a bottle with Lot 402805 or 407596 and expiration 08/2026; if so, stop using it.
- Do not use the product; contact your healthcare provider or pharmacist for guidance and a replacement if available.
- Return the affected bottle to the pharmacy or follow disposal instructions provided by the FDA or manufacturer.
How to identify the recalled item
| Lot / date codes | Lot # 402805, 407596, Exp Date: 08/2026. |
|---|---|
| Lot / date codes | Lot # 402805, 407596, Exp Date: 08/2026. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.