TEV-TROPIN Injection (Ferring) – Silicone Oil Contamination (2014)
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
TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactured in Israel, Distributed by: Gate Pharmaceuticals div. of Teva Pharmaceuticals USA Sellersville,PA 18960. NDC 57844-713-46
Brand
Ferring Pharmaceuticals Inc
Lot Codes / Batch Numbers
Lot # H11599A, Exp. 03/16 Lot # H11599B, Exp. 03/16 Lot # H12913A, Exp. 05/16 Lot # H12913B, Exp. 05/16 Lot # H12914A, Exp. 05/16 Lot # H12914B, Exp. 05/16 Lot # H13846A, Exp. 07/16 Lot # H13846B, Exp. 07/16
Products Sold
Lot # H11599A; Exp. 03/16 Lot # H11599B; Exp. 03/16 Lot # H12913A; Exp. 05/16 Lot # H12913B; Exp. 05/16 Lot # H12914A; Exp. 05/16 Lot # H12914B; Exp. 05/16 Lot # H13846A; Exp. 07/16 Lot # H13846B; Exp. 07/16
Ferring Pharmaceuticals Inc is recalling TEV-TROPIN [somatropin (rDNA origin) for injection] 5 mg (15 IU) 1-count bottle, Rx Only, Manufactur due to Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freez. 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
Chemical Contamination: TEV-TROPIN [somatropin (rDNA origin) for injection] may contain silicone oil due to leakage of a leaking line during the freeze-drying process.
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 noticeDistribution
As reported by FDA
PA
Page updated: Jan 10, 2026