Caraco Recalls Cetirizine Hydrochloride Chewable Tablets Due to Impurities
Caraco Pharmaceutical Laboratories is recalling specific lots of Cetirizine Hydrochloride Chewable Tablets because they failed impurity testing.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
Caraco Pharmaceutical Laboratories, Ltd. is recalling 128,363 bottles of Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count. The product is an over-the-counter medication manufactured by Sun Pharma in Gujarat, India, and distributed nationwide. The recall is limited to specific lots with expiration dates ranging from July 2014 to April 2015.
The recall was initiated because the product failed impurities and degradation specifications. Specifically, testing revealed out-of-specification results for N-Oxide impurities. The U.S. Food and Drug Administration has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Consumers who have these specific bottles should stop using the product and contact Caraco Pharmaceutical Laboratories or their healthcare provider for further instructions. The affected NDC is 47335-343-83.
The recalled product
- Product
- Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufactured by Sun Pharma, Gujarat, India, NDC 47335-343-83
- Manufacturer
- Caraco Pharmaceutical Laboratories, Ltd.
- Category
- Drug — Over-the-Counter
- Hazard
- Affected units
- 128,363
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- JKM2067A Exp. 07/14
- JKM2068A Exp.10/14
- JKM2069A Exp. 01/15
- JKM6399A Exp. 04/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Caraco Pharmaceutical Laboratories, Ltd. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Caraco Pharmaceutical Laboratories, Ltd.
See all →- ModerateCaraco Recalls Cephalexin Capsules Due to Manufacturing Deviations
FDA (Drugs) · 2014-08-13
- ModerateCaraco Recalls Cephalexin Capsules Due to Manufacturing Practice Deviations
FDA (Drugs) · 2014-08-13
- ModerateCaraco Recalls Venlafaxine Hydrochloride Extended-Release Tablets for Dissolution Failures
FDA (Drugs) · 2014-07-09
- SevereCaraco Recalls Gemcitabine Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-07-02
- ModerateCaraco Recalls Children's Cetirizine Tablets Due to Impurity Failures
FDA (Drugs) · 2014-05-07
Same hazard · impurities
See all →- LowDabigatran Etexilate Capsules Recalled Due to Impurity Specification Failure
FDA (Drugs) · 2026-08-05
- ModerateGlycopyrrolate Oral Solution Recalled Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-29
- ModerateMethohexital Sodium for Injection Recalled for Failed Impurities and Degradation Specifications
FDA (Drugs) · 2026-07-15
- ModerateMethohexital Sodium 100 mg/10 mL Compounded Drug Recalled Nationwide
FDA (Drugs) · 2026-07-15
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08