Elevated risk U.S. Food and Drug Administration

Amneal Pharmaceuticals Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV bag recall: Product may contain an inert fiber identified as polypropylene fibers

Recall published 1+ years ago

Product may contain an inert fiber identified as polypropylene fibers from the IV bag

Amneal Pharmaceuticals Prescription & OTC drugs — recalled prescription & otc drugsAmneal Pharmaceuticals Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Sterility or particulate concern

This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

What the notice says: Risk Statement: Introduction of polypropylene particulates into the epidural space (or inadvertent administration into the intrathecal space) may result in a variety of adverse events.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
April 18, 2025
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Amneal Pharmaceuticals
Product type
Prescription & OTC drugs
Distribution
Nationwide
Reports of harm
To date, Amneal Pharmaceuticals has received no reports of adverse events or injuries related to this recall.

Products covered by this recall

Ropivacaine Hydrochloride Injection, USP, 500mg/100mL IV bag

What the company announced

FOR IMMEDIATE RELEASE – 04/18/2025 – Bridgewater, NJ, Amneal Pharmaceutical LLC , is recalling two lots of Ropivacaine Hydrochloride Injection, USP, 500mg/100mL, Infusion bags to the hospital/user level as the products may contain an inert fiber identified as polypropylene fibers from the IV bag.

Risk Statement: Introduction of polypropylene particulates into the epidural space (or inadvertent administration into the intrathecal space) may result in a variety of adverse events. There is a reasonable probability that particulate matter in the epidural space may cause an epidural inflammatory process to meningitis or potentially damage the spinal cord. Administered intrathecally, particulate matter could result in inflammation, hydrocephalus (water on the brain), which could lead to embolization and organ damage.

To date, Amneal Pharmaceuticals has received no reports of adverse events or injuries related to this recall.

The recalled product was distributed nationwide to wholesalers/distributors between the dates of 04/23/2024 to 11/8/2024 only.

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.

Amneal is notifying its customers by UPS and is arranging for return of all recalled products. Wholesalers/distributors are asked to notify their hospital/ user customers of the recall and provide instruction to contact Amneal for the return of the recalled products to Amneal.

Hospitals/users with questions regarding this recall can contact Amneal Pharmaceuticals by:

Phone: 833-582-0812 Monday-Friday, 8:00 am-5:00 pm, EST

Fax: 631-983-2595

E-mail to: [email protected]

For Medical Inquiries or to report Adverse Events, or quality problems experienced with the use of this product, please contact Amneal Drug Safety by phone at 1-877-835-5472, Monday - Friday, 8:00 am – 6:00 pm, EST, or e-mail at [email protected] .

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online : www.fda.gov/medwatch/report.htm

Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 7 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 500mg/100mL
  • AL240003
  • AL240004

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 01/2026

NDC number

On the carton and again on the bottle or blister label.

  • 70121-1734

Package size

Match the net weight or the piece count on the front of the pack.

  • 500 mg
  • 100 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

Amneal Pharmaceuticals — This recall is about sterility assurance. It does not mean every unit is contaminated — it means the manufacturer cannot demonstrate that none of them is.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  3. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  4. Report any infection or reaction you think the product caused to FDA MedWatch.

Refunds and replacements

With medicines, a replacement supply matters more than cash, and that is what pharmacies are set up to provide.

  • Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.
  • For a mail-order or online pharmacy, use the recall line listed on this page rather than the general support queue.
  • If the recall voided a fill you had already paid for, your insurer will normally authorise a replacement ahead of schedule. Quote the recall number.
  • If you paid out of pocket, ask for a refund of the co-pay or purchase price and keep the receipt the pharmacy issues.

Company contact: Amneal Pharmaceuticals LLC. — Consumers: Amneal Drug Safety, 1-877-835-5472

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Amneal Pharmaceuticals prescription & otc drugs recalled?

Product may contain an inert fiber identified as polypropylene fibers from the IV bag Risk Statement: Introduction of polypropylene particulates into the epidural space (or inadvertent administration into the intrathecal space) may result in a variety of adverse events.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 500mg/100mL, AL240003, AL240004; best-by date 01/2026. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

Ask the dispensing pharmacy for a like-for-like replacement from an unaffected lot. This is the fastest route and usually costs nothing.

Where was the recalled product sold?

It was distributed nationwide.

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