FDA Drug recall D-0551-2026
PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicag…
- FDA Drug
- Class III
- ongoing
- Published 2026-06-03
On 2026-06-03 the FDA classified a Class III recall of PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicag… by Abbvie, citing failed Stability Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0551-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-05-18 |
| Published | 2026-06-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Abbvie |
| Distribution | US |
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
Identifiers
| ndc | 11980-174-05 |
|---|---|
| ndc | 11980-174-10 |
| code_info | Lot # 402805, 407596, Exp Date: 08/2026. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0551-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.