FDA Warns of Life-Threatening Allergic Risks as Generic Zyrtec Lots Recalled
Cross-contamination with ranitidine poses severe allergic risks for consumers, prompting a voluntary recall of four manufacturing lots.
Federal regulators have announced a nationwide voluntary recall of several lots of generic Zyrtec (cetirizine hydrochloride) due to concerns that the allergy medication may be cross-contaminated with ranitidine, a drug that could trigger severe, potentially life-threatening allergic reactions in sensitive individuals.
The U.S. Food and Drug Administration (FDA) warned that consumers with a hypersensitivity to ranitidine face a reasonable probability of experiencing anaphylaxis if they ingest the contaminated cetirizine tablets. Anaphylaxis is a rapid, severe systemic allergic reaction characterized by a sharp drop in blood pressure, breathing difficulties, swelling of the face or throat, hives, and potentially a loss of consciousness.
Ranitidine, once widely marketed under the brand name Zantac to treat heartburn and acid reflux, has a complex regulatory history in the United States. In 2020, the FDA ordered all ranitidine products off the market after discovering unacceptable levels of N-nitrosodimethylamine (NDMA), a probable human carcinogen. Although a reformulated version of the drug was approved by regulators in 2025, its unexpected presence in an over-the-counter allergy medication poses immediate health hazards to those with specific drug hypersensitives.
The manufacturing defect came to light when an alert pharmacy technician noticed visual discrepancies while dispensing the medication. Some of the tablets exhibited unusual discoloration, including distinct red dots or multiple red spots on their surfaces.
The recall, initiated by Unique Pharmaceutical Laboratories—a division of India-based J.B. Chemicals & Pharmaceuticals Ltd.—specifically targets 5 mg cetirizine hydrochloride tablets packaged in 100-count high-density polyethylene bottles. The affected product bears the National Drug Code (NDC) 16571-401-10 and includes four distinct manufacturing lots: GY825029, GY825030, GY825031, and GY825032. All of the recalled lots carry an expiration date of October 2028.
The contaminated lots were distributed nationwide to various wholesalers and retail pharmacies. To date, Unique Pharmaceutical Laboratories has not received any reports of adverse medical events or injuries linked to the recalled tablets. The manufacturer has notified its U.S. distributor, Rising Pharma Holdings Inc., to coordinate the return of the affected inventory.
Consumers who believe they have purchased the recalled medication are advised to stop using it immediately. Rising Pharma Holdings can be reached for inquiries at 1-844-874-7464 or via email at pv@risingpharma.com.
