Guardian Drug Co. Inc.: FDA regulatory profile
Guardian Drug Co. Inc. appears in 23 indexed U.S. FDA records: 23 recall records, naming 22 distinct products. Latest dated event: a recall record dated 2026-06-10. Observations run 2026-06-10 to 2026-06-10, 23 dated records across 1 calendar year, busiest 2026 with 23. Recalls: 23 Class II (100%); 23 ongoing by lifecycle status, reported 2026-06-10; 23 with an FDA recall number, 23 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: KIRKLAND Signature (D-0557-2026, Class II, 2026-06-10), HALEON CALCIUM CARBONATE TUMS ANTACID (D-0558-2026, Class II, 2026-06-10), HALEON CALCIUM CARBONATE TUMS ANTACID (D-0559-2026, Class II, 2026-06-10) and Good Neighbor Pharmacy (D-0560-2026, Class II, 2026-06-10). Recalling-firm addresses are recorded in NJ. Its recall lines are grouped by the FDA into 1 event identifier: 99098.
Regulatory snapshot
| Indexed records | 23 |
|---|---|
| Recall records | 23 |
| Shortage entries | 0 |
| Source rows filed | 0 |
| Approval records | 0 |
| Current shortages | 0 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 22 |
| Recall classifications | Class II: 23 |
| Recall statuses | Ongoing: 23 |
| First observed | 2026-06-10 |
| Latest observed | 2026-06-10 |
| Latest event type | recall |
| Dated observations | 23 |
| Years covered | 1 |
| Span (days) | 0 |
| Busiest year | 2026 (23 records) |
| Recall states | 1 |
| With recall number | 23 of 23 |
| 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 II | 23 | 100% |
| Recall status | Ongoing | 23 | 100% |
Recall history (23)
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.
Browse the wider classification index: Class II recalls.
Products and drugs named (22)
De-duplicated by record entity, not raw source row.
Source limitations
Built from the 23 ingested FDA records for this firm (23 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.