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FDAClass III · Drug · Recalled June 3, 2026
PRED MILD recall — AbbVie Inc.
Hazard: Failed Stability Specifications
Class III: not likely to cause adverse health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- D-0551-2026
- Brand
- AbbVie
- Classification
- Class III
- Units affected
- 2,736 bottles
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
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.
Affected products
Companies & origin
- Recalling firm location
- North Chicago, IL, United States
- Firm address
- 1 N Waukegan Rd, 60064-1802
Identifying details (verbatim from the notice)
- Product codes / lots
- Lot # 402805, 407596, Exp Date: 08/2026.
- Distribution
- US Nationwide.
- Firm notified the public via
- Letter
- FDA event ID
- 99008
- Recall initiated
- May 18, 2026
- FDA classified
- May 27, 2026
- FDA report date
- June 3, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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