Ropivacaine Hydrochloride Injection recall
FDA recall D-0402-2025 · initiated Apr 17, 2025
Amneal Pharmaceuticals, LLC recalled Ropivacaine Hydrochloride Injection in Apr 2025 — an FDA Class I recall (D-0402-2025) because Presence of Particulate Matter.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Presence of Particulate Matter
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 62 (12x100mL) bags
Details
- Product
- 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)
- Recalling company
- Amneal
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the US
- Initiated
- Apr 17, 2025
- FDA report date
- May 14, 2025
Frequently asked
- Was Ropivacaine Hydrochloride Injection recalled?
- Amneal Pharmaceuticals, LLC recalled Ropivacaine Hydrochloride Injection in Apr 2025 — an FDA Class I recall (D-0402-2025) because Presence of Particulate Matter. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Ropivacaine Hydrochloride Injection recalled?
- Per the FDA enforcement record, the reason for recall D-0402-2025 was: Presence of Particulate Matter
- Is a recalled Ropivacaine Hydrochloride Injection dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Ropivacaine Hydrochloride Injection are affected?
- Distributed: Nationwide in the US. The recall covers these lots — Lot #'s: AL240003, AL240004, Exp.: 01/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0402-2025.