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Amneal Pharmaceuticals, LLC

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Class I

  • The FDA’s most serious category — a reasonable probability of serious harm or death.
  • Refunds don't require a receipt, and you don't need proof of purchase.
  • FDA status: Ongoing.

What was recalled

Source: FDA · synced 29 Jul 2026 13:14
Check with your pharmacist Filed 2025-05-14

Presence of Particulate Matter

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)

Check these codes: Lot #'s: AL240003, AL240004, Exp.: 01/31/2026

62 (12x100mL) bags · distributed nationwide in the us Recall D-0402-2025 on FDA.gov ↗
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