Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0125-2018·Announced 2017-12-27

Teva Recalls Amethyst Oral Contraceptive Tablets Due to Incorrect Labeling

Teva Pharmaceuticals is recalling Amethyst oral contraceptive tablets because the packaging incorrectly states that Week 4 tablets are inactive, when all tablets are active.

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 due to a labeling error that could lead to incorrect usage, but the hazard is limited to the potential for temporary or medically reversible adverse health consequences rather than serious injury or death.

Plain-English summary

Teva Pharmaceuticals USA is recalling 5,374 blister cards of Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispensers. The recall is due to a labeling error where the blister foil and package insert state "TABLETS IN WEEK 4 ARE INACTIVE," although all tablets in the package are active.

The affected product is Lot # 544637A, NDC-52544-295-28. The product was distributed nationwide in the USA and Puerto Rico. The tablets were manufactured by Warner Chilcott Company, LLC in Fajardo, Puerto Rico, and distributed by Actavis Pharma, Inc. in Parsippany, NJ.

Consumers should stop using the product and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product: Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx only, Manufactured by: Warner Chilcott Company, LLC Fajardo, Puerto Rico 00738: Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA, NDC-52544-295-28
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Oral Contraceptive
Hazard: mis-labeling

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 (1)

Lot # 544637A

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Teva Pharmaceuticals USA

See all →

Moderate
Doxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-02-09
Low
Prescription Drug Recall: Mimvey Mislabeling by Teva Pharmaceuticals
FDA (Drugs) · 2022-02-09
Moderate
Tretinoin Capsules 10 mg Recalled for Failed Dissolution Specifications
FDA (Drugs) · 2022-02-09
Low
Mimvey Estradiol/Norethindrone Prescription Drug Mislabeling Recall
FDA (Drugs) · 2022-02-09
Moderate
Brinzolamide Ophthalmic Suspension recalled for defective container caps
FDA (Drugs) · 2022-01-26

Same hazard · mis labeling