Arformoterol Tartrate Inhalation Solution (Glenmark) – Sterility Concern (2021)
Class II: 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
Class II recall indicates potential for temporary health effects.
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
Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured by: Glenmark Pharmaceuticals Inc., USA Monroe, NC 28110 Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 a) 60x2 mL Sterile Unit-Dose Vials NDC 68462-833-65; b) 30x2 mL Sterile Unit-Dose Vials NDC 68462-833-35
Brand
Glenmark Pharmaceuticals Inc., USA
Lot Codes / Batch Numbers
Lots: a) 30210041 Exp. 03/31/2023, 30210045 Exp. 04/30/2023, 30210046 Exp. 04/30/2023, 30210050 Exp. 03/31/2023, 30210051 Exp. 04/30/2023, 30210058 Exp. 04/30/2023, b) 30210042 Exp. 03/31/2023, 30210047 Exp. 04/30/2023, 30210048 Exp. 04/30/2023, 30210052 Exp. 04/30/2023, 30210053 Exp. 04/30/2023, 30210054 Exp. 04/30/2023, 30210059 Exp. 04/30/2023, 30210060 Exp. 04/30/2023, 30210061 Exp. 04/30/2023, 30210062 Exp. 04/30/2023, 30210063 Exp. 04/30/2023, 30210064 Exp. 05/31/2023
Products Sold
Lots: a) 30210041 Exp. 03/31/2023; 30210045 Exp. 04/30/2023; 30210046 Exp. 04/30/2023; 30210050 Exp. 03/31/2023; 30210051 Exp. 04/30/2023; 30210058 Exp. 04/30/2023; b) 30210042 Exp. 03/31/2023; 30210047 Exp. 04/30/2023; 30210048 Exp. 04/30/2023; 30210052 Exp. 04/30/2023; 30210053 Exp. 04/30/2023; 30210054 Exp. 04/30/2023; 30210059 Exp. 04/30/2023; 30210060 Exp. 04/30/2023; 30210061 Exp. 04/30/2023; 30210062 Exp. 04/30/2023; 30210063 Exp. 04/30/2023; 30210064 Exp. 05/31/2023
Glenmark Pharmaceuticals Inc., USA is recalling Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Rx Only Manufactured due to Lack of Assurance of Sterility. 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
Lack of Assurance of Sterility
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