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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- AvKARE
- Product type
- Oral Contraceptive Tablet (Combined Pill)
- Model numbers
- LF41138A
- UPC codes
- 42291-565, 42291-565-28, 42291-565-84
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 2, 2025
Reported by FDA DRUG
October 15, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
Industry Context
This recall is not described as part of a broader industry pattern.
Practical Guidance
How to identify if yours is affected
- Check carton NDC 42291-565-84
- Check blister NDC 42291-565-28
- Verify Lot LF41138A
Where to find product info
Packaging on carton and blister contains NDCs, lot number, and expiry date
What timeline to expect
Remedy processing timelines are not specified; expect guidance by mail and provider consultation within weeks
If the manufacturer is unresponsive
- Contact your pharmacist or healthcare provider for alternatives
- Refer to FDA recall page for updates
- File a consumer complaint if needed
How to prevent similar issues
- Inspect NDC codes when purchasing prescription pills
- Verify lot and expiry before use
- Consult a healthcare provider for alternatives if indicated by a recall
Documentation advice
Keep packaging, take photos of the lot and NDC codes, document health concerns and communications with AvKARE or a clinician
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Product Details
Product: Norgestimate and Ethinyl Estradiol Tablets, USP. Dosages: 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, 0.25 mg/0.025 mg. Packaging: 3 Units, 3x28 tablets blister cards per carton. Form: Rx only. Manufactured for AvKARE, Pulaski, TN 38478. Carton NDC: 42291-565-84. Blister NDC: 42291-565-28. Quantity recalled: 2192 cartons. Recall date: 2025-09-02. Status: Active. Hazard: Failed Content Uniformity Specifications. Remedy: Stop using the product. Contact AvKARE or your healthcare provider for guidance. Link: FDA enforcement report D-0007-2026. Lot numbers: LF41138A. Expiration: 06/30/2027. Route
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Lot LF41138A
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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