Teva Recalls Estradiol Vaginal Inserts Due to Applicator Dispensing Issues
Teva Pharmaceuticals is recalling Estradiol Vaginal Inserts because patients reported difficulty dispensing the tablet from the applicator.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a functional defect (difficulty dispensing) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Teva Pharmaceuticals USA is recalling Estradiol Vaginal Inserts, USP 10 mcg, due to product complaints regarding difficulty in dispensing the tablet from the applicator. The affected product is a prescription medication packaged in cartons of 8 or 18 inserts.
The recall involves specific lots of the vaginal inserts distributed within the United States and Puerto Rico. The issue is a defective container that makes it difficult to use the applicator as intended.
Consumers and healthcare providers should stop using the affected Estradiol Vaginal Inserts and contact their healthcare provider or Teva Pharmaceuticals for further instructions.
The recalled product
- Product
- ESTRADIOL (ESTRADIOL)
- Brand
- ESTRADIOL
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Drug
- Affected units
- 640,486
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 (20)
- Lot #: a) 33812545A
- 33812546A
- 33812774A
- Exp. 12/2018
- 33812775A
- Exp. 01/2019
- 33812776A
- 33812777A
- Exp. 05/2019
- 33813786A
- 33813868A
- Exp. 7/2019
- 33813974A
- 33814058A
- Exp. 09/2019
- 33814113A
- b) 33812547A
- 33813361A
- 33813676A
- Exp. 1/2019
Distribution
Distributed in 1 state:
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