Amneal Pharmaceuticals, LLC drug recall: Ropivacaine Hydrochloride Injection
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Drugs
- Classification
- Class I
- Status
- Terminated
- Event ID
- 96648
- Recall initiated
- Apr 17, 2025
- Classified by FDA
- May 5, 2025
- Posted in Enforcement Report
- May 14, 2025
- Terminated
- Oct 5, 2026
- Recalling firm
- Amneal Pharmaceuticals, LLC
- Firm location
- Bridgewater, NJ, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Presence of Particulate Matter
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Apr 17, 2025. FDA classified it 18 days later, on May 5, 2025. Distribution reported by FDA: Nationwide in the US Amneal Pharmaceuticals, LLC has 16 recalls in our records.
Recalled products (1)
D-0402-2025 Class I Terminated
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)
Codes / lots: Lot #'s: AL240003, AL240004, Exp.: 01/31/2026
Quantity: 62 (12x100mL) bags
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA drug enforcement dataset
- Official notice
- FDA Enforcement Report, event 96648
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.