If you fight fall allergies with this possible swap for Zyrtec, Claritin, or Allegra, the FDA warns it's been recalled due to a manufacturing mix-up.
Between late summer and the first frost of winter, ragweed pollen and mold spores from fallen leaves commonly trigger fall allergy response. These irritants can amp up your immune system and lead to symptoms like sneezing, itchy eyes, congestion, and a runny nose, explains the American College of Asthma, Allergy, & Immunology. That’s where antihistamines usually come in handy, with the ACAAI advising should ideally start two weeks before you anticipate symptoms to arrive.
But if you’re reaching for fast-acting relief, there’s one over-the-counter option to double-check. According to an updated notice from the U.S. Food and Drug Administration (FDA) dated October 17, a total of 23,378 bottles of Cetirizine Hydrochloride Tablets have been recalled due to a manufacturing issue. Cetirizine hydrochloride happens to be the active ingredient found in medications like Zyrtec, Allegra, and Claritin, though none of these brands are affected by this recall.
The recall appears to have been first initiated on September 19 after the FDA states “Tablet/Capsules Imprinted with Wrong ID” were discovered. While the medication inside reportedly is the indicated antihistamine, the labeling error could confuse users who study their pills closely—especially if the pills are stored outside their original bottles.
The affected antihistamines were made by Unique Pharmaceuticals Labs, a division of J.B. Chemicals & Pharmaceuticals Ltd. in Mumbai, India, and distributed by Rising Pharma Holdings, Inc., based in East Brunswick, New Jersey.
In addition to their expiration date of January 31, 2028, these are the details to look out for:
100-Tablet Bottles
- Quantity: 9,936 bottles
- NDC: 16571-402-10
- Recall ID: D-0032-2026
- Lot #: PY925014A
500-Tablet Bottles
- Quantity: 13,440 bottles
- NDC: 16571-402-50
- Recall ID: D-0033-2026
- Lot #: PY925014, PY925013
The FDA has categorized this as a Class III recall—the lowest of its three risk levels. This means the issue is “not likely to cause adverse health consequences,” the FDA says.
Cetirizine works by blocking histamine receptors to help calm the body’s allergic response, and for many people, it serves as a first-line treatment option against fall allergies. If you take antihistamines, now’s a good time to double-check your bottle—especially if you use a pill sorter or store your medication in a container other than its original packaging.
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