PRED MILD — Class III drug recall D-0551-2026
Ongoing recall by AbbVie Inc., reported 2026-06-03, distributed nationwide. Failed Stability Specifications
| Recall number | D-0551-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AbbVie Inc., North Chicago, IL, United States |
| Recall initiated | 2026-05-18 |
| Classified | 2026-05-27 |
| Reported by FDA | 2026-06-03 |
| Distributed | Nationwide (US) |
| Quantity | 2,736 bottles |
| Reason classes | specification failure |
| NDC | 11980-0174, 11980-0174-05, 11980-0174-10 |
| Lot numbers | 402805, 407596 |
| Expiration dates | 2026-08 |
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 for recall
Failed Stability Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0551-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.