Why it was recalled
Presence of Particulate Matter
Product description
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)
Lot numbers, UPCs & expiration codes
Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
Where it was sold
Nationwide in the US
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-0402-2025
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Apr 17, 2025
- FDA report date
- May 14, 2025
- Quantity
- 62 (12x100mL) bags
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amneal Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0402-2025, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96648
- Address
- 400 Crossing Blvd Fl 3
- Code information
- Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
- Postal code
- 08807-2863
- Report date
- May 14, 2025
- Product type
- Drugs
- Recall number
- D-0402-2025
- Classification
- Class I
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Product quantity
- 62 (12x100mL) bags
- Reason for recall
- Presence of Particulate Matter
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Mehsana, India, , Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807 NDC 70121-1734-1 (bag); NDC 70121-1734-3 (box)
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- Apr 17, 2025
- Initial firm notification
- Letter
- Center classification date
- May 5, 2025