Montelukast Sodium Granules (Teva) – Impurity Specification Failure (2023)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
Brand
Teva Pharmaceuticals USA Inc
Lot Codes / Batch Numbers
Lot # 3007556A, Exp 5/2023
Products Sold
Lot # 3007556A, Exp 5/2023
Teva Pharmaceuticals USA Inc is recalling Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Dis due to Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026