Class II U.S. Food and Drug Administration

Rising Pharma Holdings Cetirizine Hydrochloride Tablets USP 5 mg recall: Potential cross contamination with Ranitidine

Recall published 3 months ago

Potential cross contamination with Ranitidine

Rising Pharma Holdings Prescription & OTC drugs — recalled prescription & otc drugsRising Pharma Holdings Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)Rising Pharma Holdings Prescription & OTC drugs — recalled prescription & otc drugs (photo 3)
3 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Drug safety concern

A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

What the notice says: Risk Statement: For consumers with a hypersensitivity to the ingredients in ranitidine, there is a reasonable probability that ingestion of Cetirizine tablets contaminated with ranitidine could result in serious adverse events including severe hypersensitivity reactions and anaphylaxis that manifests as hypotension, dyspnea, difficulty swallowing, throat and facial edema, generalized pruritic, urticaria, and loss of consciousness, which are all life-threatening.

Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.

Recall details

Recall number
D-0724-2026
Published
July 18, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Rising Pharma Holdings
Product type
Prescription & OTC drugs
Units affected
74208 units
Distribution
Nationwide
Lot / code info
Lots: Batch # CR2518, Exp. 11/2027; Batch # CR2601, Exp. 12/2027; CR2602, CR2603, Exp. 01/2028; CR2604, CR2605, Exp. 02/2028.

Products covered by this recall

Cetirizine Hydrochloride Tablets USP 5 mg

What the company announced

FOR IMMEDIATE RELEASE – July 18th, 2026 – Panoli, Gujarat, Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) is voluntarily recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg to the consumer level due to cross contamination with Ranitidine.

Risk Statement: For consumers with a hypersensitivity to the ingredients in ranitidine, there is a reasonable probability that ingestion of Cetirizine tablets contaminated with ranitidine could result in serious adverse events including severe hypersensitivity reactions and anaphylaxis that manifests as hypotension, dyspnea, difficulty swallowing, throat and facial edema, generalized pruritic, urticaria, and loss of consciousness, which are all life-threatening. To date, Unique Pharmaceuticals has not received any reports of adverse events related to this recall.

The product is used as an Antihistamine and is packaged in HDPE Bottle pack of 100 tablets (NDC: 16571-401-10).

Product complaint received that a pharmacy technician identifies the discrepancy while counting the tablets at the time of dispensing. A product complaint reported about Appearance of red dot on Tablets of Cetirizine Hydrochloride Tablets USP 5 mg and some tablets are discolored (Appeared as discolored due to multiple red colored dots on tablets).

The product subject to this recall is listed below and packaged in HDPE bottles. The product can be identified by reviewing the product name, manufacturer details and lot number displayed on the bottle. Product was distributed Nationwide to several wholesalers/retailers.

  • NDC: 16571-401-10 · Manufacturer: Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) · Distributed By: Rising Pharma Holdings Inc. · Product Description: Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container · Lot Numbers: GY825029 · Expiration Date: 10/2028
  • NDC: 16571-401-10 · Manufacturer: Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) · Distributed By: Rising Pharma Holdings Inc. · Product Description: Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container · Lot Numbers: GY825030 · Expiration Date: 10/2028
  • NDC: 16571-401-10 · Manufacturer: Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) · Distributed By: Rising Pharma Holdings Inc. · Product Description: Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container · Lot Numbers: GY825031 · Expiration Date: 10/2028
  • NDC: 16571-401-10 · Manufacturer: Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) · Distributed By: Rising Pharma Holdings Inc. · Product Description: Cetirizine Hydrochloride Tablets USP 5 mg, Pack 100’s HDPE container · Lot Numbers: GY825032 · Expiration Date: 10/2028

Unique Pharmaceuticals has notified its distributor Rising Pharma Holdings Inc. (2 Tower Center Blvd., Suite 1401A, East Brunswick, NJ 08816) who has notified its distributors and direct customers by email and is arranging for the return of all recalled products.

Consumers with general or medical inquiries regarding this recall can contact Rising Pharma Holdings Inc. at: Phone number : 1-844-874-7464 8:00 a.m. to 5:00 p.m. (EST), (Monday-Friday) or e-mail address : [email protected] or [email protected] . Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online : www.fda.gov/medwatch/report.htm 1

Regular Mail or Fax : Download form www.fda.gov/MedWatch/getforms.htm 2 or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 19 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • GY825029
  • GY825030
  • GY825031
  • GY825032
  • Batch # CR2518
  • Exp. 11/2027
  • CR2601
  • Exp. 12/2027

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 10/2028. NDC 16571-401-10
  • 11/2027
  • 12/2027
  • 01/2028
  • 02/2028. — 74208 units

NDC number

On the carton and again on the bottle or blister label.

  • 16571-401-10
  • 64980-504-48

Package size

Match the net weight or the piece count on the front of the pack.

  • 5 mg
  • 2 mg
  • 5 mL
  • 473 mL

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Drug safety

Rising Pharma Holdings — A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.

  1. Check the lot number on your pack against the codes listed above.
  2. Keep the carton; the lot number is often printed only on the outer pack.
  3. Report side effects you think the product caused to FDA MedWatch.
  4. Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.

Getting a replacement supply

Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.

  • Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
  • Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
  • Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
  • If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.

Company contact: Unique Pharmaceutical Laboratories — Consumers: Rising Pharma Holdings Inc., 1-844-874-7464, [email protected] or [email protected]

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Rising Pharma Holdings prescription & otc drugs recalled?

Potential cross contamination with Ranitidine Risk Statement: For consumers with a hypersensitivity to the ingredients in ranitidine, there is a reasonable probability that ingestion of Cetirizine tablets contaminated with ranitidine could result in serious adverse events including severe hypersensitivity reactions and anaphylaxis that manifests as hypotension, dyspnea, difficulty swallowing, throat and facial edema, generalized pruritic, urticaria, and loss of consciousness, which are all life-threatening.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code GY825029, GY825030, GY825031; best-by date 10/2028. NDC 16571-401-10 or 11/2027. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Check the lot number on your pack against the codes listed above.

Can I get my money back?

Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.

Where was the recalled product sold?

It was distributed nationwide.

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