Allergy and antihistamine medication recalls
17 FDA-recorded recalls of allergy and antihistamines, most recent Jun 2026 — newest first, straight from the FDA's own database.
Latest recall — announced 18 July 2026
Cetirizine 5 mg tablets recalled for cross-contamination with ranitidine
Unique Pharmaceutical Laboratories (a division of J. B. Chemicals & Pharmaceuticals) is voluntarily recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg — a generic of Zyrtec, distributed by Rising Pharma Holdings — to the consumer level, after a pharmacy technician noticed red dots and discoloration on tablets while counting them. The FDA's notice states that for consumers hypersensitive to the ingredients in ranitidine, ingestion "could result in serious adverse events including severe hypersensitivity reactions and anaphylaxis"; no adverse events had been reported at the time of the announcement. Branded Zyrtec is not part of this recall.
- NDC
- 16571-401-10
- Affected lots
- GY825029, GY825030, GY825031, GY825032
Not yet in the FDA enforcement database, so it does not appear in the table below. FDA recall bulletin, 18 July 2026 ↗
Antihistamine recalls are usually packaging, potency or impurity failures on specific lots rather than a problem with the medicine. The July 2026 cetirizine recall is the unusual case: the tablets were not defective in themselves but were cross-contaminated with a second drug, which is a risk only for people sensitive to that drug. An allergy medicine is easy to replace, so if your lot is named, stop using that bottle and pick up an unaffected product.
Cetirizine Hydrochloride Tablets USP 5 mg
Class ICross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride Tablets USP 5 mg. Determined to be Ranitidine.
JB Chemicals and Pharmaceuticals Ltd · Jul 29, 2026
hydrOXYzine Hydrochloride Oral Solution
Class IIIPresence of foreign substance
ANI Pharmaceuticals, Inc. · Jul 1, 2026
Fexofenadine Hydrochloride Tablets
Class IIIFailed Impurities/Degradation Specifications
SUN PHARMACEUTICAL INDUSTRIES INC · Jul 8, 2026
Benadryl, 25'S 2PK Box, UPC 815556020316
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Jan 21, 2026
Claritin, 20 Count, UPC: 655708016305
Class IICGMP Deviations: Insanitary conditions including rodent exposure/activity in their distribution center.
GOLD STAR DISTRIBUTION INC · Jan 21, 2026
Cetirizine Hydrochloride Tablets USP 10 mg
Class IIITablet/Capsules Imprinted with Wrong ID
JB Chemicals and Pharmaceuticals Ltd · Oct 29, 2025
Cetirizine Hydrochloride Tablets USP 10 mg
Class IIITablet/Capsules Imprinted with Wrong ID
JB Chemicals and Pharmaceuticals Ltd · Oct 29, 2025
Azelastine HCl Ophthalmic Solution
Class IILack of Assurance of Sterility
Apotex Corp. · Jul 2, 2025
Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules…
Class IICGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit
Chattem Inc · Apr 23, 2025
Cetirizine Hydrochloride Tablets
Class IICGMP Deviations
Glenmark Pharmaceuticals Inc., USA · Apr 16, 2025
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x…
Class IICGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
Chattem Inc · Mar 19, 2025
Diphenhydramine HCl 50 mg
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Jan 22, 2025
Diphenhydramine HCl 25 mg
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Jan 22, 2025
Diphenhydramine HCl 25 mg
Class IIILabeling: Not Elsewhere Classified: Tablets/Capsules imprinted with wrong ID.
Akron Pharma, Inc. · Jan 22, 2025
Chlorpheniramine Maleate 4 mg tablets
Class IISuperpotent Drug: Stability failure for assay at 6 months test time-point.
BLI International, Inc. · Nov 6, 2024
Broncochem Cold & Tea (acetaminophen
Class IIStability testing failures for one or two of the four active pharmaceutical ingredients among the finished drug products, i.e., Phenylephrine HCL, and/or Chlorpheniramine Maleate.
Global Corporation · Mar 20, 2024
Fexofenadine Hydrochloride Tablets
Class IICGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
SUN PHARMACEUTICAL INDUSTRIES INC · Jan 31, 2024
How to use this page
A drug appearing here does not mean your prescription is unsafe. Recalls name specific lots and manufacturers — open the recall to see the affected lot numbers, and match them against your bottle. Never stop a blood-pressure, cholesterol, diabetes, antidepressant or antibiotic medicine on your own because of a recall; confirm your lot, then ask your pharmacist for a replacement if it is affected.
Other categories: Blood pressure medication · Eye drop and ophthalmic · Cholesterol medication · Diabetes medication · Antidepressant · Antibiotic · Thyroid medication · Hormonal and contraceptive · ADHD and stimulant medication · Opioid and pain medication · Seizure and epilepsy medication · Asthma and inhaler · Heartburn and acid-reflux medication. See also the full recalls tracker and the recall report.
Source: the openFDA drug Enforcement (recall) database. Recalls are matched to this category by the drug names in the FDA’s product description; a small number of category recalls may be missed if the description omits the ingredient. Figures are recall events, not units, and reflect our copy of the FDA data, refreshed daily. This is public regulatory data, not medical advice.