Quick Facts at a Glance
- Recall Date
- October 1, 2025
- Hazard Level
- HIGH
- Brands
- Ketorolac Tromethamine, Camber Pharmaceuticals
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Ketorolac Tromethamine, Camber Pharmaceuticals
- Product type
- Ketorolac Tromethamine Injection, 60 mg/2 mL, 2 mL single-dose vial, IM use
- Model numbers
- AS1240347A, AS1240144A, AS1240145A, AS1240146A, AS1250295A, 31722-307-25, 31722-307-02
- UPC codes
- 31722-305, 31722-306, 31722-307, 31722-305-25, 31722-305-10, 31722-306-25, 31722-307-25, 31722-307-02
- Sizes
- 2 mL
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 1, 2025
Reported by FDA DRUG
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Presence of Particulate Matter: Particulate matter identified as glass
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Aspiro Pharma Limited or your healthcare provider for guidance. Notification method: Letter
About This Product
Ketorolac Tromethamine Injection is used under medical supervision for short-term pain relief. It is supplied in 2 mL single-dose vials for intramuscular use.
Why This Is Dangerous
The presence of glass particulates in an injectable drug could cause tissue injury or other health risks if administered.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
If exposed, patients may need medical evaluation for potential glass-related injury and may require alternative analgesia.
Practical Guidance
How to identify if yours is affected
- Check the carton for NDC 31722-307-25
- Check the vial label for NDC 31722-307-02
- If affected, stop use and contact Aspiro Pharma Limited at 1-866-495-1995
Where to find product info
NDC numbers on carton and vial labels; Lot numbers on vial label; Expiration dates on packaging
What timeline to expect
Recall processing and replacement timelines not specified. Expect manufacturer guidance.
If the manufacturer is unresponsive
- Document all communications with the manufacturer
- Contact FDA MedWatch at 1-800-FDA-1088 to file a consumer complaint
- Consult your healthcare provider for alternatives
How to prevent similar issues
- Before receiving injectable drugs, verify NDC and lot numbers
- Check recall databases for updates on products
- Work with a trusted pharmacy and healthcare provider to verify drug safety
Documentation advice
Keep the recall notice, packaging, lot numbers, dates, and all correspondence with the manufacturer for records.
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Product Details
Product: Ketorolac Tromethamine Injection, USP, 60 mg/2 mL (30 mg/mL). Form: 2 mL single-dose vial. Route: Intramuscular. Rx only. Sold for Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. Manufactured by Aspiro Pharma Limited, Telangana - 502281, INDIA. NDC 31722-307-25 (Carton); 31722-307-02 (Vial label). Lots: AS1240347A, AS1240144A, AS1240145A, AS1240146A, AS1250295A. Exp: 09/2026, 05/2026, 06/2026, 05/2027. Recall date: 2025-10-01. Status: ACTIVE. Distribution: Nationwide in the United States. Contact: 1-866-495-1995. FDA recall number: D-0036-2026.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- NDC on carton: 31722-307-25
- Vial label NDC: 31722-307-02
- Recall status: ACTIVE
- Distribution: Nationwide in the U.S.
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Safety Guide
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