Cetirizine Hydrochloride Tablets USP 5 mg Recall: What To Do

jb chemicals recall notices are now in front of consumers who bought a very common allergy medicine. On July 29, 2026, the U.S. Food and Drug Administration published recall number D-0732-2026. It covers Cetirizine Hydrochloride Tablets USP 5 mg in 100-count bottles. The tablets were manufactured by Unique Pharmaceuticals Labs, a division of J.B. Chemicals & Pharmaceuticals, Ltd., in Mumbai, India. Rising Pharma Holdings, Inc., of East Brunswick, New Jersey, distributed them. The FDA classified this action as Class I. That is the agency’s most serious category.

What the Jb Chemicals Recall Covers

The jb chemicals recall applies to one specific drug product. It is Cetirizine Hydrochloride Tablets USP, 5 mg strength, packaged in 100-count bottles. The National Drug Code is NDC 16571-401-10. That number appears on the bottle label. Check it before you assume your bottle is or is not included.

Cetirizine is a second-generation antihistamine. Consumers typically use it for seasonal allergies, hives, and year-round nasal symptoms. The 5 mg strength is often used for children or for adults who need a lower dose. As a result, this recall may reach households with young family members.

The manufacturing address on the label reads Mumbai 400 030, India. The distributor address reads East Brunswick, NJ 08816. Both appear in the FDA record. However, the agency record does not list individual lot numbers in the summary above. For lot-level detail, read the official notice linked on this page.

The recall covers 34,020 units. That figure refers to the quantity the FDA recorded for this action. Bottles may have moved through pharmacies, retail shelves, or mail order. In most cases, distribution records are held by the recalling firm, not by consumers.

The Hazard and Reported Injuries

The hazard here is cross contamination with another product. The FDA record describes customer complaints about discolored tablets. Complainants also observed red dots on the cetirizine tablets. Testing determined that the contaminating substance was ranitidine.

Ranitidine is a different drug entirely. It is a histamine H2 blocker once widely sold for heartburn and acid reflux. It is not an antihistamine allergy tablet, and it is not what a cetirizine buyer expects to swallow. A person taking a contaminated tablet could receive medication they did not choose and were not prescribed. For example, someone with a known sensitivity to ranitidine would have no way to avoid it.

The FDA assigned this a Class I classification. Class I is reserved for situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death. That classification reflects agency risk judgment. It is not, by itself, a report that harm occurred.

Importantly, the agency record does not state whether any injuries have been reported in connection with this recall. This guide therefore makes no claim in either direction. Do not read the Class I label as proof of injury. Likewise, do not read the silence as proof of safety.

What To Do If You Own This Product

Start by stopping use. If you have a 100-count bottle of Cetirizine Hydrochloride Tablets USP 5 mg, set it aside. Do not keep taking tablets while you sort out whether your bottle is affected. Typically, the safest step is to pause first and verify second.

Next, identify the product carefully. Look at the bottle label for the NDC number 16571-401-10. Look for the manufacturer line naming Unique Pharmaceuticals Labs, a division of J.B. Chemicals & Pharmaceuticals, Ltd. Look for Rising Pharma Holdings, Inc., as the distributor. Also inspect the tablets themselves for discoloration or red dots.

This guide does not state what the remedy is. The agency record for this recall contains remedy text that does not match the product. As a result, that text has been withheld here rather than repeated. Follow the instructions in the official notice instead: FDA Enforcement Report — official recall notice.

Then contact the people who can help you directly. Your pharmacist can check whether your fill came from the recalled bottles. Your prescribing clinician can advise on what to take instead, especially for a child. However, do not stop a needed medication without a plan. Ask about a substitute before you go without.

Finally, keep your records. Save the bottle, the label, the receipt, and any pharmacy paperwork. Photograph the tablets if they look discolored. In most cases, physical evidence is far more useful later than memory. You can also report a problem to the FDA MedWatch program.

Does a Jb Chemicals Recall Mean You Can Sue?

A recall is not a lawsuit. That distinction matters, and it is worth stating plainly. The jb chemicals recall is a safety action taken to remove product from the market. It is a regulatory and corrective step, not a court filing and not a finding of legal liability.

As a result, the existence of the jb chemicals recall does not by itself create a legal claim for you. Owning a recalled bottle is not an injury in the legal sense. Reading about a Class I classification is not an injury either. Courts generally look for something more concrete before a claim moves forward.

In most cases, a personal injury claim involving a medication requires several elements. There must be an actual injury. There must be a link between the product and that injury, which lawyers call causation. There must be proof, typically medical records and product identification. Deadlines called statutes of limitations also apply, and they vary by state.

If you believe you were harmed, talk to a licensed attorney in your state. An attorney can review your medical history and your purchase records. You may be eligible to pursue a claim, depending on the facts. However, no one can promise you compensation, and this guide does not. This article is general education, not legal advice.

How Recalls Connect to Mass Tort Cases

Recalls and mass torts are separate things that sometimes intersect. A recall notice creates a dated public record. It names the product, the defect, and the company. As a result, that record can later become evidence in litigation, because it documents what was known and when.

History offers real examples. Philips recalled millions of CPAP and BiPAP devices in 2021 over degrading sound abatement foam. That recall was followed by consolidated federal litigation and, eventually, a reported settlement program. Takata airbag inflators were recalled across many automakers, and that recall record fed into extensive litigation and a bankruptcy proceeding. In both instances, the recall came first and the legal process came afterward.

However, most recalls never become mass torts. The overwhelming majority end quietly, with product returned or corrected and nothing further. There is no verified lawsuit reported over this jb chemicals recall as of this writing, and this guide does not suggest one exists. Typically, litigation only develops when a pattern of documented injuries emerges over time.

Frequently Asked Questions

What product is covered by the jb chemicals recall?

The jb chemicals recall covers Cetirizine Hydrochloride Tablets USP 5 mg in 100-count bottles, NDC 16571-401-10. They were manufactured by Unique Pharmaceuticals Labs, a division of J.B. Chemicals & Pharmaceuticals, Ltd., in Mumbai, India. Rising Pharma Holdings, Inc., distributed them in the United States.

Why is the jb chemicals recall classified Class I?

The FDA uses Class I for recalls where there is a reasonable probability of serious adverse health consequences or death. Here, cetirizine tablets were found to be cross contaminated with ranitidine, a different drug. Consumers also reported discolored tablets and red dots.

Have injuries been reported in the jb chemicals recall?

The FDA record for this recall does not state whether injuries have been reported. This guide therefore makes no claim either way. If you experienced a health problem after taking these tablets, contact your clinician and consider reporting it to FDA MedWatch.

Were You Injured by a Recalled Product?

A recall by itself is a safety action, not a legal claim. However, if a recalled product caused a real injury, you may be eligible to pursue compensation. A licensed attorney can review your situation at no upfront cost — most work on contingency, meaning you pay nothing unless you recover.

Official Sources & Resources

Verify every recall against the issuing agency before acting:

• U.S. Food and Drug Administration: official recall database — the record of truth for this notice
• CPSC: cpsc.gov — household goods, toys, furniture, appliances
• FDA: fda.gov — food, drugs, and medical devices
• NHTSA: nhtsa.gov — vehicles, tires, and child car seats
• USDA FSIS: fsis.usda.gov — meat, poultry, and egg products

Content last reviewed September 2026. This is general educational information, not legal advice. If you notice outdated information, please contact us.

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Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. A product recall is a safety action by a manufacturer or regulator and does not by itself establish liability or create a legal claim. No attorney-client relationship is created by accessing or using this content. Every case is unique. If you believe you were harmed by a recalled product, consult a licensed attorney in your jurisdiction.