Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination
Sandoz Inc. is recalling 18,832 bottles of Isosorbide Dinitrate 20 mg tablets due to cross-contamination with other products.
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: The recall is classified as FDA Class II, and the hazard involves cross-contamination of a prescription drug where specific injury reports are not detailed in the source, fitting the criteria for high-risk products where injury has not yet been reported or is theoretical.
Plain-English summary
Sandoz Inc. is recalling 18,832 bottles of Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles. The product is distributed nationwide within the United States. The specific lot affected is JA9535 with an expiration date of 05/2021.
The recall was initiated due to cross-contamination with other products. The source text does not specify the nature of the contaminant or the specific health risks associated with this contamination.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on next steps.
The recalled product
- Product
- ISOSORBIDE DINITRATE (ISOSORBIDE DINITRATE)
- Brand
- ISOSORBIDE DINITRATE
- Manufacturer
- Sandoz Inc
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 18,832
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 (1)
- Lots: a) JA9535 Exp. 05/2021.
UPCs (3)
- 0307811556017
- 0307811695013
- 0307811635019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Sandoz 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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