Filing Flows › AbbVie (ABBV) › Recalls, complaints & regulation
AbbVie (ABBV): recalls, EPA violations, clinical trials and Federal Register
AbbVie (ABBV) beyond its filings: 1 recall in the last 12 months (4 in five years, 0 Class I); 1 EPA-regulated facility in violation, no penalties in five years; 12 Federal Register documents in a year; 240 active clinical trials.
Latest recalls
- 2026-06-03 · FDA drug · PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only, Allergen, Inc., an AbbVie company, North Chicago, IL 60064, Product
- 2024-10-02 · FDA drug · Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madi
- 2024-10-02 · FDA drug · Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company
- 2023-11-15 · FDA drug · Synthroid, Levothyroxine Sodium Tablets, USP 125mcg (0.125mg), 100-count bottle, Rx Only AbbVie Inc. North Chicago, IL 60064, U.S.A. NDC 0074-7068-11
EPA facilities in violation
| Facility (as registered) | City | Status | Penalties |
|---|---|---|---|
| ABBVIE LTD | Barceloneta, PR | Violation | — |
Facilities in the EPA's ECHO register whose registered name matches the company's; a facility can belong to another business of the same name.
AbbVie's latest quarter
AbbVie, Q3 2026: revenue $17.4B (+10% year over year), operating margin 36.0%, net earnings $4.2B, operating cash flow $7.6B. The chart follows the revenue to costs, profit and cash.
Questions
Has AbbVie had any recalls?
4 recalls on file over five years from the FDA, CPSC and NHTSA; 1 in the last 12 months.
Has AbbVie been fined by the EPA?
The 22 EPA-regulated facilities on file under its name drew no penalties in five years; 1 is in violation now.
How many clinical trials does AbbVie have?
240 active studies on ClinicalTrials.gov, 73 in phase 3.
Updated Nov 8, 2026. Read automatically from SEC filings and public data; errors are possible. Not investment advice.