American Regent Recalls Atropine Sulfate Injection Due to Particulate Matter
American Regent, Inc. is recalling Atropine Sulfate injection vials because they contain particulate matter, including hair, glass, and paraformaldehyde.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. The presence of glass and particulate matter in an intravenous injection presents a significant risk of serious injury, meeting the criteria for a Severe rating.
Plain-English summary
American Regent, Inc. is recalling 89,775 vials of Atropine Sulfate injection, USP, 1 mg/mL. The product is packaged in 1 mL single-dose vials and 25x1 mL single-dose vial packs. The recall affects Lot #24353, which has an expiration date of 9/30/2026.
The recall was initiated because the product is contaminated with particulate matter. The specific contaminants identified include hair, glass, and/or paraformaldehyde. The affected product is intended for intravenous use and is available by prescription only.
The recalled product was distributed nationwide within the United States. Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the manufacturer for further instructions.
The recalled product
- Product
- ATROPINE SULFATE (ATROPINE SULFATE)
- Brand
- ATROPINE SULFATE
- Manufacturer
- American Regent, Inc.
- Category
- Drug — Injection
- Affected units
- 89,775
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 24353
- Exp. Date: 9/30/2026.
UPCs (2)
- 0305171004254
- 0305171001253
Distribution
Distributed nationwide across the United States.
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