Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for ...

FDA Drug Recall #D-0875-2018 — Class I — May 24, 2018

Recall Summary

Recall Number D-0875-2018
Classification Class I — Serious risk
Date Initiated May 24, 2018
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Allergan, PLC.
Location Madison, NJ
Product Type Drugs
Quantity 168,768 blister cards (4,725,504 softgel capsules)

Product Description

Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians's Sample - Not for Sale Distributed by: Allergan USA INC Irvine, CA 92612 NDC 0023-5862-28 (Blister Card) NDC 0023-5862-29 (Blister Carton) NDC 0023-5862-31 (Outer carton) UPC 300235862290

Reason for Recall

Contraceptive Tablets Out of Sequence.

Distribution Pattern

US Nationwide

Lot / Code Information

Lot# 5620706, Exp. 05/19

Other Recalls from Allergan, PLC.

Recall # Classification Product Date
D-0233-2021 Class II Refresh Relieva PF Preservative-Free Lubricant ... Dec 30, 2020
D-0387-2019 Class II OZURDEX (dexamethasone intravitreal implant) 0.... Dec 20, 2018

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.