Class III · Low risk
Cetirizine Hydrochloride Tablets USP 10 mg
Tablet/Capsules Imprinted with Wrong ID
Cetirizine Hydrochloride Tablets USP 5 mg
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Cross 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.
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B. Chemicals & Pharmaceuticals, Ltd.), Mumbai 400 030, India. Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, NDC 16571-401-10.
Affected NDC
16571-0401-10
Compare with the code on your package — it is the most precise check available.
Drug: Cetirizine Category: Allergy & Cold Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Cetirizine Hydrochloride NDC 16571-0401 |
5 mg/1 | Tablet Oral |
Rising Pharma Holdings, Inc. | OTC |
- Recalling firm
- JB Chemicals and Pharmaceuticals Ltd
- NDC code
- 16571-401-10
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Jul 18, 2026 · FDA notice with lot numbers
- FDA recall number
- D-0732-2026 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.
Other Cetirizine recalls
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Class III · Low risk
Cetirizine Hydrochloride Tablets USP 10 mg
Tablet/Capsules Imprinted with Wrong ID
Class II · Moderate risk
Cetirizine Hydrochloride Tablets
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Class II · Moderate risk
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CGMP Deviations: product held outside appropriate storage temperature conditions.
Class III · Low risk
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Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count tablets.
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Class II · Moderate risk
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Class III · Low risk
Cetirizine Hydrochloride Tablets USP 10 mg
Tablet/Capsules Imprinted with Wrong ID
Class III · Low risk
Cetirizine Hydrochloride Tablets USP 10 mg
Tablet/Capsules Imprinted with Wrong ID
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