drugs MODERATE Updated 2026-08-26

American Regent, Inc. recalls ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a

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Recalled Product

ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.

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Hazard / Issue

Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall