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.
USPRED 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 Firm: AbbVie Inc.
Reason for Recall / Hazard
Failed Stability Specifications
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | North Chicago |
| State | IL |
| Openfda › Upc | 0311980174101 |
| Openfda › Unii | 8B2807733D |
| Openfda › Route | OPHTHALMIC |
| Openfda › Rxcui › 1 | 209002 |
| Openfda › Rxcui › 2 | 562379 |
| Openfda › Spl id | 02594e74-d6cf-40b5-bfb1-c27be33e0e35 |
| Openfda › Brand name | PRED MILD |
| Openfda › Spl set id | 4fcce64a-94ea-4031-ad5a-c4eddc73a910 |
| Openfda › Package ndc › 1 | 11980-174-05 |
| Openfda › Package ndc › 2 | 11980-174-10 |
| Openfda › Product ndc | 11980-174 |
| Openfda › Generic name | PREDNISOLONE ACETATE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | PREDNISOLONE ACETATE |
| Openfda › Manufacturer name | Allergan, Inc. |
| Openfda › Application number | NDA017100 |
| Openfda › Is original packager | true |
| Event id | 99008 |
| Address 1 | 1 N Waukegan Rd |
| Code info | Lot # 402805, 407596, Exp Date: 08/2026. |
| Postal code | 60064-1802 |
| Report date | 20260603 |
| Product type | Drugs |
| Product quantity | 2,736 bottles |
| Reason for recall | Failed Stability Specifications |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260518 |
| Initial firm notification | Letter |
| Center classification date | 20260527 |
Check Other Products In Your Household
Free Safety ToolsSafety recalls are issued daily across foods, medications, vehicles, and electronics. Use our instant tools to check your home for active safety warnings:
Overview
- Recalling FirmAbbVie Inc.
- StatusOngoing
- Risk LevelClass III
- DistributionUS Nationwide.
📢 Share Warning
Alert family and friends to keep them safe. Copy this quick alert message:
🚨 SAFETY ALERT: AbbVie Inc. - 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. Check if your household is affected: https://therecallfile.com/recalls/pred-mild-prednisolone-acetate-ophthalmic-suspension-usp-0-12-10-ml-st/FDA-D-0551-2026
Join Alertlist
Get instant email updates whenever critical safety recalls like this are published.
Featured on Product Hunt
Help support our public safety mission and check out our community launch.
Support The Recall File
Help keep official recall alerts free, accessible, and fast for everyone.
Related Recalls
UKMHRA Safety Roundup: August 2026
MHRA Safety Roundup: August 2026
Summary of the latest safety advice for medicines and medical device users...
AustraliaCAROTONE skin-brightening products found to contain undeclared prescription-only medicine
CAROTONE skin-brightening products found to contain undeclared prescription-only medicine
We are advising consumers that CAROTONE products marketed for skin brightening may pose a serious risk to your health and should not be used....
UKClass 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
Class 2 Medicines Recall: Zentiva Pharma UK Limited, Fingolimod Zentiva 0.5 mg Capsules, EL(26)A/37
Zentiva UK Pharma Limited are recalling one batch of Fingolimod Zentiva 0.5 mg Capsules (BN 4L01372H) as a precautionary measure due to a potential risk of contamination with metal particles....