Accord Healthcare, Inc.: FDA regulatory profile
Accord Healthcare, Inc. appears in 7 indexed U.S. FDA records: 1 recall record and 6 drug-shortage entries (from 12 openFDA source rows), naming 7 distinct products. Latest dated event: a shortage record dated 2026-08-20. Observations run 2012-01-01 to 2026-08-20 — 5345 days, 13 dated records across 4 calendar years, busiest 2026 with 7. Recalls: 1 Class II (100%); 1 ongoing by lifecycle status, reported 2026-07-08; 1 with an FDA recall number, 1 with an initiation date, across 1 state, grouped into 1 FDA recall event. Shortages: 6 current, averaging 2 package lines each across 7 FDA therapeutic categories, 9 strengths, 95 package NDCs and 5 brand names. 6 related firms and 8 adjacent shortage entries are linked below, each by a shared shortage entry, substance or therapeutic category. 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.
Regulatory snapshot
| Indexed records | 7 |
|---|---|
| Recall records | 1 |
| Shortage entries | 6 |
| Source rows filed | 12 |
| Approval records | 0 |
| Current shortages | 6 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 7 |
| Recall classifications | Class II: 1 |
| Recall statuses | Ongoing: 1 |
| First observed | 2012-01-01 |
| Latest observed | 2026-08-20 |
| Latest event type | shortage |
| Dated observations | 13 |
| Years covered | 4 |
| Span (days) | 5345 |
| Busiest year | 2026 (7 records) |
| Lines per entry (mean) | 2 |
| Therapeutic categories | 7 |
| Distinct strengths | 9 |
| Package NDCs | 95 |
| Brand names | 5 |
| Recall states | 1 |
| With recall number | 1 of 1 |
| FDA recall events | 1 |
| Related firms / shortages | 6 / 8 |
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 | 1 | 100% |
| Recall status | Ongoing | 1 | 100% |
| Shortage status | Current | 6 | 100% |
| Therapeutic category | Anesthesia | 2 | 33% |
| Therapeutic category | Neurology | 2 | 33% |
| Therapeutic category | Oncology | 2 | 33% |
| Therapeutic category | Pediatric | 2 | 33% |
| Therapeutic category | Cardiovascular | 1 | 17% |
| Therapeutic category | Psychiatry | 1 | 17% |
| Therapeutic category | Rheumatology | 1 | 17% |
Current shortages (6)
Reported by this firm and recorded by the FDA as active. Each links to its canonical entry.
| Shortage | Status | Since | Updated | Lines filed | Presentations | Strengths |
|---|---|---|---|---|---|---|
| Dexmedetomidine Hydrochloride Injection (Dexmedetomidine IN Dextrose, Precedex) | Current | 2020-04-10 | 2026-08-20 | 1 | 1 | 100 ug/1 mL |
| Atropine Sulfate Injection | Current | 2012-01-01 | 2026-08-18 | 4 | 4 | .05 mg/1 mL, .1 mg/1 mL, .4 mg/1 mL, 1 mg/1 mL |
| Carboplatin Injection (Kyxata, Paraplatin) | Current | 2023-04-28 | 2026-08-18 | 3 | 3 | 10 mg/1 mL |
| Furosemide Injection | Current | 2020-04-07 | 2026-08-18 | 1 | 1 | 10 mg/1 mL |
| Clonazepam Tablet (Klonopin) | Current | 2023-03-10 | 2026-08-17 | 2 | 2 | .5 mg, 1 mg |
| Methotrexate Sodium Injection | Current | 2023-03-13 | 2026-08-17 | 1 | 1 | 25 mg/1 mL |
Package lines filed (12)
The openFDA shortage lines this firm filed, with the agency's own availability text.
| Shortage | Presentation | Strength | Package NDC | Status | Availability (FDA text) | Updated |
|---|---|---|---|---|---|---|
| Dexmedetomidine Hydrochloride Injection | Dexmedetomidine Hydrochloride, Injection, 100 ug/1 mL (NDC 16729-239-93) | 100 ug/1 mL | 16729-239-93 | Current | Unavailable | 2026-08-17 |
| Atropine Sulfate Injection | Atropine Sulfate, Injection, .4 mg/1 mL (NDC 16729-512-43) | .4 mg/1 mL | 16729-512-43 | Current | Unavailable | 2026-08-17 |
| Atropine Sulfate Injection | Atropine Sulfate, Injection, 1 mg/1 mL (NDC 16729-526-08) | 1 mg/1 mL | 16729-526-08 | Current | Unavailable | 2026-08-17 |
| Atropine Sulfate Injection | Atropine Sulfate, Injection, .1 mg/1 mL (NDC 16729-484-90) | .1 mg/1 mL | 16729-484-90 | Current | Unavailable | 2026-08-17 |
| Atropine Sulfate Injection | Atropine Sulfate, Injection, .05 mg/1 mL (NDC 16729-483-03) | .05 mg/1 mL | 16729-483-03 | Current | Unavailable | 2026-08-17 |
| Carboplatin Injection | Carboplatin, Injection, 10 mg/1 mL (NDC 16729-295-34) | 10 mg/1 mL | 16729-295-34 | Current | Unavailable | 2026-08-17 |
| Carboplatin Injection | Carboplatin, Injection, 10 mg/1 mL (NDC 16729-295-33) | 10 mg/1 mL | 16729-295-33 | Current | Unavailable | 2026-08-17 |
| Carboplatin Injection | Carboplatin, Injection, 10 mg/1 mL (NDC 16729-295-31) | 10 mg/1 mL | 16729-295-31 | Current | Unavailable | 2026-08-17 |
| Furosemide Injection | Furosemide, Injection, 10 mg/1 mL (NDC 16729-501-43) | 10 mg/1 mL | 16729-501-43 | Current | Unavailable | 2026-08-17 |
| Clonazepam Tablet | Clonazepam, Tablet, 1 mg (NDC 16729-137-16) | 1 mg | 16729-137-16 | Current | Available | 2026-08-17 |
| Clonazepam Tablet | Clonazepam, Tablet, .5 mg (NDC 16729-136-00) | .5 mg | 16729-136-00 | Current | Available | 2026-08-17 |
| Methotrexate Sodium Injection | Methotrexate Sodium Preservative Free, Injection, 25 mg/1 mL (NDC 16729-277-35) | 25 mg/1 mL | 16729-277-35 | Current | Available | 2026-08-17 |
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 |
|---|---|---|---|---|---|
| Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactu | D-0656-2026 | Class II | Ongoing | 2026-07-08 | 2026-06-08 |
Browse the wider classification index: Class II recalls.
Products and drugs named (7)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| Atropine Sulfate Injection | shortage | 4 | 2026-08-18 |
| Carboplatin Injection | shortage | 3 | 2026-08-18 |
| Clonazepam Tablet | shortage | 2 | 2026-08-17 |
| Dexmedetomidine Hydrochloride Injection | shortage | 1 | 2026-08-20 |
| Furosemide Injection | shortage | 1 | 2026-08-18 |
| Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles | recall | 1 | 2026-07-08 |
| Methotrexate Sodium Injection | shortage | 1 | 2026-08-17 |
Indexed activity by year
Counts within the ingested window across 13 dated records — not a trend.
| Year | Recalls | Shortage observations | Approvals | Total |
|---|---|---|---|---|
| 2026 | 1 | 6 | 0 | 7 |
| 2023 | 0 | 3 | 0 | 3 |
| 2020 | 0 | 2 | 0 | 2 |
| 2012 | 0 | 1 | 0 | 1 |
Related manufacturers
Linked by a co-reported shortage entry or a shortage of the same active substance — never inferred from name or sector.
| Firm | Relation | Records | Recalls | Shortages | Latest |
|---|---|---|---|---|---|
| American Regent, Inc. | co-reports the same shortage | 2 | 1 | 1 | 2026-08-18 |
| Amphastar Pharmaceuticals, Inc. | co-reports the same shortage | 6 | 0 | 6 | 2026-08-18 |
| Avet Pharmaceuticals, Inc. | co-reports the same shortage | 2 | 0 | 2 | 2026-08-18 |
| Azurity Pharmaceuticals, Inc | co-reports the same shortage | 1 | 0 | 1 | 2026-08-20 |
| Baxter Healthcare | co-reports the same shortage | 14 | 0 | 14 | 2026-08-20 |
| Cheplapharm Arzneimittel Gmbh | co-reports the same shortage | 1 | 0 | 1 | 2026-08-17 |
Related shortages in this firm's areas
Not reported by this firm, but sharing a substance identifier or therapeutic category with one that is.
| Shortage | Status | Relation | Since | Updated | Presentations | Firms |
|---|---|---|---|---|---|---|
| Dexamethasone Sodium Phosphate Injection | Current | same therapeutic category | 2019-02-08 | 2026-08-20 | 4 | 1 |
| Midazolam Hydrochloride Injection | Current | same therapeutic category | 2020-04-02 | 2026-08-18 | 4 | 2 |
| Bumetanide Injection | Current | same therapeutic category | 2017-12-13 | 2026-08-21 | 6 | 2 |
| Etomidate Injection | Current | same therapeutic category | 2022-10-05 | 2026-08-20 | 2 | 1 |
| Rocuronium Bromide Injection | Current | same therapeutic category | 2023-02-15 | 2026-08-20 | 6 | 4 |
| Bupivacaine Hydrochloride Injection | Current | same therapeutic category | 2018-02-20 | 2026-08-18 | 1 | 1 |
| Conivaptan Hydrochloride Injection | Current | same therapeutic category | 2022-03-14 | 2026-08-18 | 1 | 1 |
| Dextrose Monohydrate 50% Injection | Current | same therapeutic category | 2022-01-13 | 2026-08-18 | 1 | 1 |
Source limitations
Built from the 7 ingested FDA records for this firm (1 recall, 6 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.