CLASS II ONGOING Drug recall · Reported 26 Aug 2026 · FDA Enforcement Report
Atropine Sulfate injection, USP, 1 mg/mL recalled by American Regent
American Regent is recalling Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, distributed nationwide in the US. The recall was initiated on 24 Jul 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0795-2026
- FDA event ID
- 99503
- Recalling firm
- American Regent, Shirley, NY
- Brand
- Atropine Sulfate
- Manufacturer
- American Regent, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jul 2026
- FDA classified
- 26 Aug 2026
- Reported
- 26 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Jul 2026 | Recall initiated by company | |
| 26 Aug 2026 | Classified by FDA | +33 days |
| 26 Aug 2026 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Product as listed by the FDA
Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRLEY, NY 11967.
Where it was distributed
Nationwide within the U.S
Questions about this recall
Is Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile recalled?
Yes. American Regent recalled Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile on 24 Jul 2026. The recall is Class II and its status is Ongoing. Recall number D-0795-2026.
Why was it recalled?
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Which lots are affected?
Lot #: 24353, Exp. Date: 9/30/2026.
Where was it sold?
Nationwide within the U.S
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from American Regent
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Food | ANNOUNCED | Epinephrine Injection, USP 30 mg/ (1 mg/mL) multi dose vial recalledAmerican Regent, Inc. | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Tralement (trace elements injection 4*, USP) recalled by American RegentTralement | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only recalledCyanocobalamin | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Selenious Acid Injection, USP 12 mcg/ (6 mcg/, For intravenous use recalledSelenious Acid | American Regent | Particulate Matter | Nationwide |
| Drug | CLASS II | Aminaocaproic Acid Injection, USP, 250 mg/mL recalled by American RegentAminocaproic Acid | American Regent | Particulate Matter | Nationwide |
Other Atropine recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Atropine Sulfate Injection, USP 1 mg/ 1 mg/mL), Lifeshield recalledAtropine Sulfate | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | Atropine Sulfate Injection, USP 8 mg per 4 mg per mL) recalledAtropine Sulfate | Accord Healthcare | Particulate Matter | Nationwide |
| Drug | CLASS II | Atropine Sulfate Injection, USP 2 mg/ 4 mg/mL) syringe recalled | Nephron Sterile Compounding Center | Sterility | Nationwide |
| Drug | CLASS II | Isopto Atropine (atropine sulfate ophthalmic solution) recalledIsopto Atropine | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Atropine Sulfate Injection, 8 mg/ 4 mg/mL) Single Dose Syringe recalled | SCA Pharmaceuticals | Sterility | Nationwide |