CLASS III ONGOING Drug recall · Reported 3 Jun 2026 · FDA Enforcement Report
Pred Mild, prednisolone acetate ophthalmic suspension recalled by AbbVie
AbbVie is recalling Pred Mild, prednisolone acetate ophthalmic suspension, USP, 0.12%, Sterile, distributed nationwide in the US. The recall was initiated on 18 May 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0551-2026
- FDA event ID
- 99008
- Recalling firm
- AbbVie, North Chicago, IL
- Brand
- Pred Mild
- Manufacturer
- Allergan, Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 18 May 2026
- FDA classified
- 27 May 2026
- Reported
- 3 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 18 May 2026 | Recall initiated by company | |
| 27 May 2026 | Classified by FDA | +9 days |
| 3 Jun 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Failed Stability Specifications
Which lots are affected?
Lot # 402805, 407596, Exp Date: 08/2026.
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Prednisolone recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Prednisolone Oral Solution, USP, 15 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | PrednisoLONE Oral Solution USP, 15 mg recalled by Akorn | Akorn | Packaging Defects | Nationwide |
| Drug | CLASS II | Prednisolone Acetate Ophthalmic Suspension recalledPrednisolone Acetate | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Prednisolone Sodium Phosphate Oral Solution, 5 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |