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Cetirizine Hydrochloride
Cetirizine Hydrochloride recalls: 6 FDA reports
Recalls involving Cetirizine Hydrochloride. What was wrong with each batch, and how the FDA graded the risk.
6Reports
0Class I
2Ongoing
2025-10-29Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs,
D-0032-2026 · Class III · reported 2025-10-29 · Ongoing
- Why it was recalled
- Tablet/Capsules Imprinted with Wrong ID
- Product
- Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles, 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 16571-402-10.
- Where it went
- U.S. Nationwide
- How much
- 9936 bottles
Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, Manufactured by: Unique Pharmaceuticals Labs,
D-0033-2026 · Class III · reported 2025-10-29 · Ongoing
- Why it was recalled
- Tablet/Capsules Imprinted with Wrong ID
- Product
- Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles, 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 16571-402-50
- Where it went
- U.S. Nationwide
- How much
- 13,440 bottles
Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyvi
D-0096-2022 · Class III · reported 2021-11-17 · Terminated
- Why it was recalled
- 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.
- Product
- Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3
- Where it went
- FL, IN, MN, WI
- How much
- 72 bottles
children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 F
D-0277-2019 · Class II · reported 2018-11-21 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
- Product
- children's allergy (cetirizine hydrochloride) Oral Solution, 1 mg/mL, ANTIHISTAMINE, Dye-Free, Sugar-Free, 4 FL OZ (120 mL) bottle, Distributed by Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811, NDC 56062-106-08, UPC 0 41415 43573 5.
- Where it went
- Nationwide in the USA
- How much
- 8328 bottles
Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSen
D-0525-2016 · Class III · reported 2015-12-30 · Terminated
- Why it was recalled
- Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester
- Product
- Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter under the following brands, GoodSense brand distributed by Perrigo, Allegan, MI; Equaline brand distributed by; Supervalu Inc, Eden Prairie, MN (NDC 41163-458-66); Good Neighbor Pharmacy brand, distributed by AmerisourceBergen, Chesterbrook, PA (NDC 24385-998-74); HEB brand, San Antonio, TX (NDC 37808-458-66); Rexall brand Packaged for Dolgencorp LLC, Goodlettsville, TN (NDC 55910-699-66 UPC: 370030659432), HyVee brand, distributed by Hy-Vee Inc., West Des Mones, IA (NDC 42507-458-66); Smart Sense brand distributed by Kmart Corporation, Hoffman Estates, IL (NDC 49738-458-66); Kroger brand distributed by The Kroger Co, Cincinnati, OH (NDC 30142-458-66); Leader brand distributed by Cardinal Health, Dublin, OH (NDC 49781-106-14; CVS Pharmacy brand distributed by CVS Pharmacy, Inc., Woonsocket, RI (NDC 59779-458-66); Healthy Accents brand distributed by DZA Brands, LLC, Salisbury, NC (NDC 55316-458-66); Safeway Care brand distributed by Safeway Inc., Pleasanton, CA (NDC 21130-458-66); Topcare brand distributed by Topsco Associates, LLC, Skokie, IL (NDC 36800-458-66); Wal-Zyr brand distributed by Walgreens Co,...
- Where it went
- Nationwide
- How much
- 209,256 cartons
Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Privat
D-008-2013 · Class III · reported 2012-10-24 · Terminated
- Why it was recalled
- Impurity/Degradation; exceeded impurity specification at the 8 and 15 month time points (betacyclodextrin ester 1&2)
- Product
- Children's Cetirizine HCl Chewable Tablets 5 mg, 30 count blister pack, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ NDC 0781-5283-64 --- ALSO sold under Major brand All Day Allergy Children's Cetirizine HCl 5 mg, 5 count blister pack, Major Pharmaceuticals, Livonia, MI NDC 0904-5878-33
- Where it went
- Nationwide
- How much
- 67,937 x 30 tablet cartons; 24,640 x 5 tablet cartons
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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