Why it was recalled
Failed Stability Specifications
Product description
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.
Lot numbers, UPCs & expiration codes
Lot # 402805, 407596, Exp Date: 08/2026.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0551-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- May 18, 2026
- FDA report date
- Jun 3, 2026
- Quantity
- 2,736 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AbbVie Inc.
Original FDA data
Every field from FDA enforcement report D-0551-2026, exactly as published.
Show all FDA fields
- City
- North Chicago
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 99008
- Address
- 1 N Waukegan Rd
- Code information
- Lot # 402805, 407596, Exp Date: 08/2026.
- Postal code
- 60064-1802
- Report date
- Jun 3, 2026
- Product type
- Drugs
- Recall number
- D-0551-2026
- Classification
- Class III
- Recalling firm
- AbbVie Inc.
- Product quantity
- 2,736 bottles
- Reason for recall
- Failed Stability Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- May 18, 2026
- Initial firm notification
- Letter
- Center classification date
- May 27, 2026