The Recall Desk
ModerateFDA (Drugs)·D-0322-2024·Announced 2024-02-21

Nortrel 7/7/7 Oral Contraceptive Recalled for Discolored Tablets

Teva Pharmaceuticals is recalling Nortrel 7/7/7 oral contraceptive tablets due to a manufacturing defect: discolored blue tablets mixed with white inert tablets. This could cause confusion about which tablets to take in the triphasic regimen.

What this means for you

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: FDA Class III classification with no reported illnesses or injuries and a theoretical hazard. Per the severity rubric, precautionary recalls with low-risk manufacturing defects are classified as Moderate.

Plain-English summary

Teva Pharmaceuticals USA, Inc. is recalling Nortrel 7/7/7 (norethindrone and ethinyl estradiol) nationwide. The recall affects 19,824 cartons with lot number 100040731 (expiration date 7/31/2024).

The reason for the recall is a manufacturing defect: blue discolored tablets were found mixed in with the white inert remainder tablets in the cartons. Nortrel 7/7/7 is packaged as a triphasic oral contraceptive regimen, in which each tablet group contains specific hormone levels for different weeks of use.

No illnesses or injuries have been reported in connection with this defect. This is a precautionary recall issued by the manufacturer.

Consumers who have this product should contact their healthcare provider or pharmacist for guidance. Do not use if the package contains discolored blue tablets mixed with white tablets.

The recalled product

Product
NORTREL 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL)
Brand
NORTREL 7/7/7
Manufacturer
Teva Pharmaceuticals USA, Inc
Hazard
  • discoloration

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 (2)

  • Lot #: 100040731
  • Exp 7/31/2024

Distribution

Distributed nationwide across the United States.