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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Allergan, PLC.: Taytulla Softgel Capsules Recalled for Out-of-Sequence Packaging Error

Agency Publication Date: June 11, 2018
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Summary

Allergan, PLC. has recalled approximately 168,768 blister cards of Taytulla (norethindrone acetate and ethinyl estradiol) softgel capsules distributed as physician samples. The recall was issued because the capsules in some packs are arranged out of sequence, meaning the first four days of the treatment pack may contain inactive placebo pills instead of active medication. This packaging defect can cause the medication to fail, which could lead to an unintended pregnancy. These affected samples were distributed to healthcare providers nationwide.

Risk

Taking the pills in the wrong order significantly reduces the effectiveness of the birth control. If a consumer takes the inactive maroon pills during the first four days of their cycle instead of the active pink pills, there is a high risk of ovulation and unintended pregnancy.

What You Should Do

  1. Check your Taytulla (norethindrone acetate and ethinyl estradiol) physician samples for lot number 5620706 with an expiration date of 05/19.
  2. Inspect the blister card to see if the first four capsules are pink (active) or maroon (inactive). If the maroon pills are in the positions for days 1 through 4, the pack is defective.
  3. If you identify an affected pack, contact your healthcare provider or pharmacist immediately to discuss using a backup non-hormonal method of contraception.
  4. Return any unused portions of the recalled lot to the healthcare provider who provided the sample or the place of purchase for a refund.
  5. Contact Allergan at 800-678-1605, Monday through Friday, between 8:00 AM and 8:00 PM ET for instructions on returning the product or to report any adverse events.
  6. For additional questions or to report a safety concern, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund

Return for refund or replacement

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund.
๐Ÿ“‹Option 2: Other Action

Medical Consultation

How to: Patients should notify their physicians and use a non-hormonal back-up method of contraception.

Affected Products

Product: Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample
Model:
NDC 0023-5862-28 (Blister Card)
NDC 0023-5862-29 (Blister Carton)
NDC 0023-5862-31 (Outer carton)
UPC Codes:
300235862290
Lot Numbers:
5620706 (Exp. 05/19)
Date Ranges: Expiration Date: 05/19

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 80136
Status: Resolved
Manufacturer: Allergan, PLC.
Sold By: Physician offices; Healthcare providers; Clinics
Manufactured In: United States
Units Affected: 168,768 blister cards (4,725,504 softgel capsules)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.