Recall archive / FDA company announcement
Amneal Pharmaceuticals LLC.: Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV bag — FDA announcement Apr 18, 2025
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Apr 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV bag
- Reason
- Product may contain an inert fiber identified as polypropylene fibers from the IV bag
- Classification
- Not supplied
- Recalling firm
- Amneal Pharmaceuticals LLC.
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- 7d56cbc0cded1044
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | The product is indicated for the production of local or regional anesthesia for surgery and or acute pain management and is packaged in 12x100mL Single Dose IV bags (NDC 70121-17343). The affected Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, products are Lot AL240003 (exp 01/2026) and Lot AL240004 (exp 01/2026). No other Ropivacaine Hydrochloride Injection, USP lots are impacted. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
The recalled product was distributed nationwide to wholesalers/distributors between the dates of 04/23/2024 to 11/8/2024 only.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Fda listing date
- Apr 18, 2025
- Company announcement date
- Apr 18, 2025
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.