Zydus Pharmaceuticals (usa) Inc: FDA regulatory profile
Zydus Pharmaceuticals (usa) Inc appears in 3 indexed U.S. FDA records: 3 recall records, naming 3 distinct products. Latest dated event: a recall record dated 2026-08-12. Observations run 2026-05-27 to 2026-08-12 — 77 days, 3 dated records across 1 calendar year, busiest 2026 with 3. Recalls: 3 Class II (100%); 3 ongoing by lifecycle status, reported 2026-05-27 to 2026-08-12; 3 with an FDA recall number, 3 with an initiation date, across 1 state, grouped into 2 FDA recall events. 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: Mirabegron Extended-Release Tablets (D-0745-2026, Class II, 2026-08-12), Erythromycin Tablets (D-0544-2026, Class II, 2026-05-27) and Erythromycin Tablets (D-0545-2026, Class II, 2026-05-27). Recalling-firm addresses are recorded in NJ. Its recall lines are grouped by the FDA into 2 event identifiers: 98870 and 99563. Distribution is recorded in the source as Nationwide in the USA and Nationwide within the U.S.
Regulatory snapshot
| Indexed records | 3 |
|---|---|
| Recall records | 3 |
| Shortage entries | 0 |
| Source rows filed | 0 |
| Approval records | 0 |
| Current shortages | 0 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 3 |
| Recall classifications | Class II: 3 |
| Recall statuses | Ongoing: 3 |
| First observed | 2026-05-27 |
| Latest observed | 2026-08-12 |
| Latest event type | recall |
| Dated observations | 3 |
| Years covered | 1 |
| Span (days) | 77 |
| Busiest year | 2026 (3 records) |
| Recall states | 1 |
| With recall number | 3 of 3 |
| FDA recall events | 2 |
| 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 | 3 | 100% |
| Recall status | Ongoing | 3 | 100% |
Recall history (3)
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 |
|---|---|---|---|---|---|
| Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufactured by: Zyd | D-0745-2026 | Class II | Ongoing | 2026-08-12 | 2026-08-05 |
| Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus | D-0544-2026 | Class II | Ongoing | 2026-05-27 | 2026-04-29 |
| Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus | D-0545-2026 | Class II | Ongoing | 2026-05-27 | 2026-04-29 |
| FDA recall event | Records | Classification(s) | First reported | Last reported |
|---|---|---|---|---|
| 98870 | 2 | Class II | 2026-05-27 | 2026-05-27 |
| 99563 | 1 | Class II | 2026-08-12 | 2026-08-12 |
Browse the wider classification index: Class II recalls.
Products and drugs named (3)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Man | recall | 1 | 2026-05-27 |
| Erythromycin Tablets, USP, 500 mg, 30 tablets per bottle, Rx only, Man | recall | 1 | 2026-05-27 |
| Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, | recall | 1 | 2026-08-12 |
Source limitations
Built from the 3 ingested FDA records for this firm (3 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.