Accord Healthcare Recalls Atropine Sulfate Injection for Particulate Matter Contamination
Accord Healthcare is recalling Atropine Sulfate Injection due to the presence of particulate matter identified as fiber. Two lots totaling 2,348 vials have been distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a parenteral (injectable) drug with confirmed physical contamination. While no reported illnesses or injuries are documented, the presence of particulate matter in injectable medications represents a risk-of-harm product where injury has not yet been reported, meeting the rubric criterion for a High (3) severity rating.
Plain-English summary
Accord Healthcare, Inc. is recalling Atropine Sulfate Injection, USP 8 mg per 20 mL (manufactured by Intas Pharmaceuticals Limited in India), due to the presence of particulate matter identified as fiber in the product.
The affected product is supplied in 20 mL multiple-dose vials. Two specific lots have been identified: Lot M2210154 with expiration date 06/2025 and Lot M2212575 with expiration date 08/2025. A total of 2,348 vials have been distributed nationwide within the United States.
Atropine Sulfate is a prescription-only injectable medication. The presence of particulate matter in injectable medications poses a potential health risk and is the reason for this recall.
Healthcare providers and customers who have received affected vials should immediately discontinue use and contact Accord Healthcare for instructions regarding product return and replacement.
The recalled product
- Product
- ATROPINE SULFATE (ATROPINE SULFATE)
- Brand
- ATROPINE SULFATE
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Injectable / Parenteral
- Affected units
- 2,348
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 #: M2210154 Exp. date 06/2025
- M2212575 Exp. date 08/2025
UPCs (1)
- 0316729512053
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Accord Healthcare, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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