ACETYLCYSTEINE SOLUTION recall
FDA recall D-0797-2026 · initiated Jul 24, 2026
American Regent, Inc. recalled ACETYLCYSTEINE SOLUTION in Jul 2026 — an FDA Class II recall (D-0797-2026) because Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
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: 169,200 vials
Details
- 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.
- Recalling company
- American Regent, Inc.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the U.S
- Initiated
- Jul 24, 2026
- FDA report date
- Aug 26, 2026
Frequently asked
- Was ACETYLCYSTEINE SOLUTION recalled?
- American Regent, Inc. recalled ACETYLCYSTEINE SOLUTION in Jul 2026 — an FDA Class II recall (D-0797-2026) because Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was ACETYLCYSTEINE SOLUTION recalled?
- Per the FDA enforcement record, the reason for recall D-0797-2026 was: Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
- Is a recalled ACETYLCYSTEINE SOLUTION 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. May cause temporary or medically reversible harm; low probability of serious harm. 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 ACETYLCYSTEINE SOLUTION are affected?
- Distributed: Nationwide within the U.S. The recall covers these lots — Lot #: 24426, Exp. Date: 11/30/2026; 25220, Exp. Date: 5/31/2027.. 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-0797-2026.