Wells Pharma OF Houston LLC: FDA regulatory profile
Wells Pharma OF Houston LLC appears in 7 indexed U.S. FDA records: 7 recall records, naming 7 distinct products. Latest dated event: a recall record dated 2026-05-06. Observations run 2026-05-06 to 2026-05-06, 7 dated records across 1 calendar year, busiest 2026 with 7. Recalls: 7 Class II (100%); 7 ongoing by lifecycle status, reported 2026-05-06; 7 with an FDA recall number, 7 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: Phenylephrine Hydrochloride Injectable Solution (D-0502-2026, Class II, 2026-05-06), fentaNYL Citrate Injectable Solution (D-0503-2026, Class II, 2026-05-06), fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride (D-0504-2026, Class II, 2026-05-06) and fentaNYL Citrate Injectable Solution (D-0505-2026, Class II, 2026-05-06). Recalling-firm addresses are recorded in TX. Its recall lines are grouped by the FDA into 1 event identifier: 98694.
Regulatory snapshot
| Indexed records | 7 |
|---|---|
| Recall records | 7 |
| Shortage entries | 0 |
| Source rows filed | 0 |
| Approval records | 0 |
| Current shortages | 0 |
| Resolved shortages | 0 |
| Discontinued shortages | 0 |
| Unique products | 7 |
| Recall classifications | Class II: 7 |
| Recall statuses | Ongoing: 7 |
| First observed | 2026-05-06 |
| Latest observed | 2026-05-06 |
| Latest event type | recall |
| Dated observations | 7 |
| Years covered | 1 |
| Span (days) | 0 |
| Busiest year | 2026 (7 records) |
| Recall states | 1 |
| With recall number | 7 of 7 |
| 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 | 7 | 100% |
| Recall status | Ongoing | 7 | 100% |
Recall history (7)
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 (7)
De-duplicated by record entity, not raw source row.
| Product / drug | Record type | Lines | Date |
|---|---|---|---|
| fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg | recall | 1 | 2026-05-06 |
| fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5 | recall | 1 | 2026-05-06 |
| fentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic | recall | 1 | 2026-05-06 |
| fentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL ( | recall | 1 | 2026-05-06 |
| fentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 | recall | 1 | 2026-05-06 |
| Ketamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Vo | recall | 1 | 2026-05-06 |
| Phenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wel | recall | 1 | 2026-05-06 |
Source limitations
Built from the 7 ingested FDA records for this firm (7 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.