CLASS III Drug recall · Reported 9 Dec 2020 · FDA Enforcement Report
Levocetirizine Dihydrochloride Tablets, USP, 5 mg recalled
InvaTech Pharma Solutions is recalling Levocetirizine Dihydrochloride Tablets, USP, 5 mg, distributed nationwide in the US. The recall was initiated on 11 Nov 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0115-2021
- FDA event ID
- 86708
- Recalling firm
- InvaTech Pharma Solutions, East Brunswick, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 11 Nov 2020
- FDA classified
- 3 Dec 2020
- Reported
- 9 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Allergy Medication
Timeline
| 11 Nov 2020 | Recall initiated by company | |
| 3 Dec 2020 | Classified by FDA | +22 days |
| 9 Dec 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Levocetirizine Dihydrochloride Tablets, USP, 5 mg 30-count bottle, Rx Only, Distributed by: Marlex Pharmceuticals, Inc. New Castle, DE 19720. NDC 10135-0639-30
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Levocetirizine Dihydrochloride Tablets, USP, 5 mg recalled?
Yes. InvaTech Pharma Solutions recalled Levocetirizine Dihydrochloride Tablets, USP, 5 mg on 11 Nov 2020. The recall is Class III and its status is Terminated. Recall number D-0115-2021.
Why was it recalled?
Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Which lots are affected?
Lot #: 051944A Exp. Date April - 2021; 1119124 Exp Date Oct - 2021; 062088 Exp Date June - 2022;
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.