Why it was recalled
Presence of Particulate Matter: Particulate matter identified as glass
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).
Lot numbers, UPCs & expiration codes
Lot #: AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027.
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0036-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 1, 2025
- FDA report date
- Oct 29, 2025
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aspiro Pharma Limited
Original FDA data
Every field from FDA enforcement report D-0036-2026, exactly as published.
Show all FDA fields
- City
- Siddipet (District)
- Status
- Ongoing
- Country
- India
- Event ID
- 97711
- Address
- Survey No. 321, Biotech Park, Phase Iii
- Address (line 2)
- Karkapatla Village, Markook (Mandal)
- Code information
- Lot #: AS1240347A, Exp Date 09/2026; AS1240144A, Exp Date 05/2026; AS1240145A, AS1240146A, Exp Date 06/2026; AS1250295A, Exp Date 05/2027.
- Report date
- Oct 29, 2025
- Product type
- Drugs
- Recall number
- D-0036-2026
- Classification
- Class II
- Recalling firm
- Aspiro Pharma Limited
- Reason for recall
- Presence of Particulate Matter: Particulate matter identified as glass
- 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).
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Oct 1, 2025
- Initial firm notification
- Letter
- Center classification date
- Oct 21, 2025