Mimvey Lo Tablets (Teva) – impurity specification (2017)
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
Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister card (NDC 0093-5454-18), packaged in 3 blister cards per carton (NDC 0093-5454-62), Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Brand
Teva Pharmaceuticals USA
Lot Codes / Batch Numbers
Lot # 33809881A, Exp 05/17, 33811151A, Exp 08/17
Products Sold
Lot # 33809881A, Exp 05/17; 33811151A, Exp 08/17
Teva Pharmaceuticals USA is recalling Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 28 tablets per blister c due to Failed Impurities/Degradation Specifications: out of specification test results for the norethindrone impurity.. 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: out of specification test results for the norethindrone impurity.
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