Ketorolac Tromethamine Injection — Class II drug recall D-0036-2026
Ongoing recall by Aspiro Pharma Limited, reported 2025-10-29, distributed nationwide. Presence of Particulate Matter: Particulate matter identified as glass
| Recall number | D-0036-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aspiro Pharma Limited, Siddipet (District), India |
| Recall initiated | 2025-10-01 |
| Classified | 2025-10-21 |
| Reported by FDA | 2025-10-29 |
| Distributed | Nationwide (US) |
| Reason classes | foreign material, specification failure |
| NDC | 31722-0305, 31722-0305-10, 31722-0305-25, 31722-0306, 31722-0306-25, 31722-0307, 31722-0307-02, 31722-0307-25 |
| Lot numbers | AS1240144A, AS1240145A, AS1240146A, AS1240347A, AS1250295A |
| Expiration dates | 2026-05, 2026-06, 2026-09, 2027-05 |
Product
Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL), 2 mL Single-Dose Vial, For Intramuscular Use Only, Rx only, Mfd. for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Mfd. by: ASPIRO PHARMA LIMITED, Telangana - 502281, INDIA., U.S. Contact Number: 1-866-495-1995, NDC 31722-307-25 (Carton), 31722-307-02 (Vial label).
Reason for recall
Presence of Particulate Matter: Particulate matter identified as glass
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-0036-2026. 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.