Ibuprofen Lysine Injection — Class I drug recall D-0637-2017
Terminated recall by X-Gen Pharmaceuticals Inc., reported 2017-04-12, distributed nationwide. Presence of Particulate Matter
| Recall number | D-0637-2017 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | X-Gen Pharmaceuticals Inc., Horseheads, NY, United States |
| Recall initiated | 2017-02-08 |
| Classified | 2017-04-05 |
| Reported by FDA | 2017-04-12 |
| Terminated | 2020-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 2,593 cartons |
| Reason classes | specification failure |
| NDC | 39822-1030, 39822-1030-01, 39822-1030-02 |
Product
Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC 39822-1030-1), packaged in 3 x 2 mL Single-Dose Vials per carton (NDC 39822-1030-2); Rx only, Distributed by: X-Gen Pharmaceuticals, Inc., Big Flats, NY 14814; Manufactured by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
Reason for recall
Presence of Particulate Matter
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0637-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.