HIGH

AvKARE Recalls Norgestimate and Ethinyl Estradiol Tablets Due to Hazard

AvKARE recalled 2,192 cartons of Norgestimate and Ethinyl Estradiol Tablets on September 2, 2025. The tablets failed content uniformity specifications, posing a high hazard risk. Consumers should stop using the product immediately and consult their healthcare provider.

Quick Facts at a Glance

Recall Date
September 2, 2025
Hazard Level
HIGH
Brand
AvKARE
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Failed Content Uniformity Specifications

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact AvKARE or your healthcare provider for guidance. Notification method: Letter

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Product Details

The recalled products include Norgestimate and Ethinyl Estradiol Tablets, USP, in three strengths: 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg. They were distributed nationwide in the U.S. The affected lot number is LF41138A, with an expiration date of June 30, 2027.

The Hazard

The recall stems from a failure to meet content uniformity specifications. This failure can result in inconsistent dosing, leading to potential health risks.

Reported Incidents

No specific incidents, injuries, or deaths have been reported in connection with this recall. The risk remains high due to the nature of the dosage inconsistency.

What to Do

Consumers should stop using the recalled tablets immediately. Contact AvKARE or your healthcare provider for guidance and further information.

Contact Information

For more information, call AvKARE at 1-800-XXXX-XXXX. Additional details can be found at the FDA's recall page.

Key Facts

  • Recall date: September 2, 2025
  • Quantity recalled: 2,192 cartons
  • Affected lot: LF41138A
  • Expiration date: June 30, 2027
  • High hazard risk due to dosage inconsistency

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeNorgestimate and Ethinyl Estradiol Tablets
Sold At
Multiple Retailers

Product Details

Brand
Model Numbers
Lot # LF41138A
Exp 06/30/2027
UPC Codes
42291-565
42291-565-28
42291-565-84
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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