Amneal Pharmaceuticals, LLC 2025-05-14 Health critical FDA
Health · FDA · Recall #FDA-D-0402-2025
Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured… Recall
Issued May 14, 2025 · Amneal Pharmaceuticals, LLC
In May 2025, Amneal Pharmaceuticals, LLC recalled the Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Presence of Particulate Matter
What you should do
- 1 Stop using Ropivacaine Hydrochloride Injection, USP, 0.5%, 500 mg per 100 mL (5mg/mL), Manufactured… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Amneal Pharmaceuticals, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Amneal Pharmaceuticals, LLC
- Category
- Health
- Recall date
- May 14, 2025
- Units affected
- Not reported
- Sold at
- Nationwide in the US
- Recall number
- FDA-D-0402-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Amneal Pharmaceuticals, LLC has 6 recalls in our database, including 2 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.