CLASS III Drug recall · Reported 17 Nov 2021 · FDA Enforcement Report
Cetirizine hydrochloride recalled by A-S Medication Solutions
A-S Medication Solutions is recalling Cetirizine hydrochloride, distributed in Florida, Indiana, Minnesota, Wisconsin. The recall was initiated on 5 Oct 2021 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-0096-2022
- FDA event ID
- 88853
- Recalling firm
- A-S Medication Solutions, Libertyville, IL
- Brand
- Cetirizine
- Manufacturer
- A-S Medication Solutions
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 5 Oct 2021
- FDA classified
- 5 Nov 2021
- Reported
- 17 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Drug class
- Allergy Medication
Timeline
| 5 Oct 2021 | Recall initiated by company | |
| 5 Nov 2021 | Classified by FDA | +31 days |
| 17 Nov 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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 as listed by the FDA
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 was distributed
FL, IN, MN, WI
Questions about this recall
Is Cetirizine hydrochloride recalled?
Yes. A-S Medication Solutions recalled Cetirizine hydrochloride on 5 Oct 2021. The recall is Class III and its status is Terminated. Recall number D-0096-2022.
Why was it 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.
Which lots are affected?
Lot #: 1256330
Where was it sold?
FL, IN, MN, WI
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.
More recalls from A-S Medication Solutions
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metformin Hydrochloride Extended- Release 500mg recalledMetformin Hydrochloride | A-S Medication Solutions | Packaging Defects | Nationwide |
| Drug | CLASS I | Acetaminophen Extra Strength Tablets, 500 mg each recalledAcetaminophen | A-S Medication Solutions | Labeling Errors | Nationwide |
| Drug | CLASS I | Acetaminophen, Extra Strength, Aspirin Free, Mfr recalledAcetaminophen | A-S Medication Solutions | Packaging Defects | Nationwide |
| Drug | CLASS II | Valsartan Tablets, 160 MG bottle recalled by A-S Medication Solutions | A-S Medication Solutions | Potency & Assay | Nationwide |
| Drug | CLASS II | Valsartan and Hydrochlorothiazide Tablets recalled | A-S Medication Solutions | Potency & Assay | Nationwide |
Other Cetirizine recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cetirizine Hydrochloride Tablets USP 5 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Cetirizine Hydrochloride Tablets, USP, 10mg packs recalledCetirizine Hcl | Glenmark Pharmaceuticals Inc., U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cetirizine Hydrochloride Tablets, 10 mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |