Abbvie Inc.: FDA regulatory profile
Abbvie Inc. appears in 1 indexed U.S. FDA record: 1 recall record, naming 1 distinct product. Latest dated event: a recall record dated 2026-06-03. Observations run 2026-06-03 to 2026-06-03, 1 dated record across 1 calendar year, busiest 2026 with 1. Recalls: 1 Class III (100%); 1 ongoing by lifecycle status, reported 2026-06-03; 1 with an FDA recall number, 1 with an initiation date, across 1 state, grouped into 1 FDA recall event. Every figure here is a count or a date computed from the indexed FDA datasets over a finite window: coverage-limited activity signals, never quality ratings or judgements about the firm. Recall records: PRED MILD (D-0551-2026, Class III, 2026-06-03). Recalling-firm addresses are recorded in IL. Its recall lines are grouped by the FDA into 1 event identifier: 99008. Distribution is recorded in the source as US Nationwide. Recalling-firm country of record: United States. Recall initiation dates run 2026-05-18 across 1 record. This firm appears in 1 indexed record, which is below the threshold this site requires before treating a manufacturer page as a standalone regulatory profile (only 1 indexed record). The page is published so the record remains reachable and verifiable, and it links on to the underlying FDA records, but it is marked noindex and left out of the sitemap: a single appearance of a company name is not a regulatory history, and presenting it as one would overstate what the data supports. Should further records reference this firm in a later ingestion, the page becomes a full profile automatically.
Regulatory snapshot
| Indexed records | 1 |
|---|---|
| Recall records | 1 |
| Shortage entries | 0 |
| Source rows filed | 0 |
| Approval records | 0 |
| Current shortages | 0 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 1 |
| Recall classifications | Class III: 1 |
| Recall statuses | Ongoing: 1 |
| First observed | 2026-06-03 |
| Latest observed | 2026-06-03 |
| Latest event type | recall |
| Dated observations | 1 |
| Years covered | 1 |
| Span (days) | 0 |
| Busiest year | 2026 (1 records) |
| Recall states | 1 |
| With recall number | 1 of 1 |
| FDA recall events | 1 |
| Related firms / shortages | 0 / 0 |
Counts, not a rating. Coverage-limited activity signals over the ingested window — never reputational scores or judgements about the firm or its products.
Record breakdown
| Dimension | Value | Records | Share |
|---|---|---|---|
| Recall classification | Class III | 1 | 100% |
| Recall status | Ongoing | 1 | 100% |
Recall history (1)
Every enforcement report attributed to this firm, newest first. Classification is the FDA's severity tier, status its lifecycle position — neither is a safety statement.
| Product (as published) | Recall number | Classification | Status | Reported | Initiated |
|---|---|---|---|---|---|
| PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 mL, Sterile, Rx only | D-0551-2026 | Class III | Ongoing | 2026-06-03 | 2026-05-18 |
Browse the wider classification index: Class III recalls.
Products and drugs named (1)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| PRED MILD, prednisolone acetate ophthalmic suspension, USP, 0.12%, 10 | recall | 1 | 2026-06-03 |
Source limitations
Built from the 1 ingested FDA record for this firm (1 recall, 0 shortage, 0 approval) — not its full regulatory history. The window is finite and can lag the live record, and alternate spellings of a firm name may sit under separate profiles. Confirm details at the linked official source. Regulatory information only: no safety assessment, no recommendation.
How to read these records
Where to go next
Source & provenance
- Official source
- https://open.fda.gov/apis/drug/enforcement/
- Source dataset
- openFDA (enforcement + shortages + Drugs@FDA)
- Publication date
- Not available
- Ingested
- 2026-08-22
Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.