Xyzal was not pulled from the market for safety reasons. The prescription version of Xyzal (levocetirizine) has been formally discontinued in the United States, but the medication itself is still widely available, both as an over-the-counter brand product called Xyzal Allergy 24HR and as generic levocetirizine. What most people are encountering is the aftermath of a common pharmaceutical shift: a brand-name prescription drug moving to OTC status, making the original prescription version unnecessary.
The Prescription-to-OTC Switch
Xyzal originally required a prescription in the U.S. In February 2017, the FDA approved Sanofi’s Xyzal Allergy 24HR for over-the-counter sale. Once a drug becomes available without a prescription, manufacturers typically stop producing the prescription version. There’s little financial incentive to maintain it when consumers can buy the same active ingredient off the shelf.
Both the 5 mg tablet and the 2.5 mg/5 mL oral solution of prescription Xyzal are now listed as discontinued in the FDA’s records. This doesn’t mean the drug disappeared. It means the specific prescription product is no longer marketed under that approval. The OTC version contains the same medication at the same dose.
Generic Competition Played a Role
Once a brand-name drug loses patent protection, generic manufacturers can produce their own versions. Generic levocetirizine is now made by multiple companies and is significantly cheaper than the brand-name product. This is a standard pattern in the pharmaceutical industry: brand-name prescription drugs lose market share to generics, and the original manufacturer shifts its business strategy, in this case toward the OTC market where brand recognition still drives sales.
If you’ve been prescribed levocetirizine and your pharmacy says it’s unavailable, they may be referring to a specific generic manufacturer’s version. Supply disruptions among individual generic makers are common and usually temporary. Your pharmacist can check whether another manufacturer’s generic is in stock.
No Safety Recall or Withdrawal
Xyzal has never been withdrawn in any country due to safety concerns. Levocetirizine tablets and oral solutions are registered in over 60 countries worldwide. The FDA did add a warning that stopping levocetirizine (or the related drug cetirizine) after long-term use can cause rare but severe itching, a rebound effect identified in about 209 cases reported globally between 2017 and 2023. That warning was a labeling update, not a recall or a reason for discontinuation.
Why Your Insurance Stopped Covering It
One of the most noticeable consequences of the OTC switch is that many insurance plans dropped coverage for levocetirizine. Most insurers, including TRICARE, do not cover over-the-counter medications. TRICARE’s formulary, for example, covers OTC cetirizine, fexofenadine, and loratadine with a prescription, but levocetirizine is not on that list.
If you previously got Xyzal through your insurance with a small copay and now find it costs $20 to $30 out of pocket for the OTC version, this is why. Generic levocetirizine tablets from store brands or online pharmacies are often the most affordable option, typically costing less than the Xyzal Allergy 24HR brand.
The OTC Product Is Still Active
Sanofi continues to manufacture and sell Xyzal Allergy 24HR. As recently as July 2025, the FDA approved a packaging update for Children’s Xyzal Allergy 24HR, adding new bottle sizes in grape and bubble gum flavors. This is not a product line winding down. It’s one that’s actively expanding.
If you’re having trouble finding Xyzal on pharmacy shelves, it’s most likely a temporary stocking issue rather than a sign the product has been pulled. The tablets and children’s liquid are both available at major retailers and online pharmacies. For the prescription-strength tablet (5 mg), the OTC version is identical, so no prescription is needed to continue taking it.