# FDA recall D-0036-2026

> **Aspiro Pharma Limited** · Class II · drug recall initiated 2025-10-01.

## 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

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0036-2026
- **Recalling firm:** Aspiro Pharma Limited
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-01
- **Report date:** 2025-10-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Siddipet (District), India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0036-2026

## Citation

> AI Analytics. FDA recall D-0036-2026. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/D-0036-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*