Home / Recalls / Aspiro Pharma Limited / D-0036-2026

D-0036-2026 Class II Ongoing

Recalled by Aspiro Pharma Limited — Siddipet (District)

FDA drug recall D-0036-2026 was initiated by Aspiro Pharma Limited on Oct 1, 2025 and is designated Class II. Reason for recall: Presence of Particulate Matter: Particulate matter identified as glass The recall status is ongoing.

Recall details

Product Type: Drugs
Report Date: Oct 29, 2025
Initiation Date: Oct 1, 2025
Voluntary/Mandated: Voluntary: Firm initiated

Product description

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

Distribution pattern

Nationwide within the United States

Code information

Lot #: AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027.

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0036-2026
openFDA file date: Nov 10, 2026
Loaded by RegDataLab: Nov 11, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.