CLASS III Drug recall · Reported 3 Nov 2021 · FDA Enforcement Report
Loratadine-D Extended-Release Tablets (Loratadine recalled
SUN Pharmaceutical Industries is recalling Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, distributed nationwide in the US. The recall was initiated on 12 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-0068-2022
- FDA event ID
- 88806
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Manufacturer
- Major Pharmaceuticals
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 12 Oct 2021
- FDA classified
- 26 Oct 2021
- Reported
- 3 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Allergy Medication
Timeline
| 12 Oct 2021 | Recall initiated by company | |
| 26 Oct 2021 | Classified by FDA | +14 days |
| 3 Nov 2021 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Moisture Limits
Product as listed by the FDA
Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Moisture Limits
Which lots are affected?
Lot #: AC14635, Exp. Date 12/2022
Where was it sold?
Nationwide within the United States
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 88806This product is part of a recall event; the main page for the event is AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate recalledKirkland Signature Allerclear D 24 Hr | SUN Pharmaceutical Industries | Other | Nationwide |
More recalls from SUN Pharmaceutical Industries
All 138| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carbamazepine Tablets, USP, 200mg recalled | SUN Pharmaceutical Industries | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled | SUN Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel | SUN Pharmaceutical Industries | Packaging Defects | Nationwide |
| Drug | CLASS I | DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
| Drug | CLASS II | Budesonide Inhalation Suspension, 1mg recalledBudesonide | SUN Pharmaceutical Industries | Particulate Matter | Nationwide |
Other Loratadine recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate recalledKirkland Signature Allerclear D 24 Hr | SUN Pharmaceutical Industries | Other | Nationwide |
| Drug | CLASS II | Children's Loratadine Oral Solution USP, 5 mg recalledChildrens Loratadine | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS III | Ohm Loratadine Orally Disintegrating Tablets recalledAllergy Relief | Ohm Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Non-Drowsy 24 Hour Formula Allergy Relief recalled by Ohm LaboratoriesLoratadine And Pseudoephedrine Sulfate | Ohm Laboratories | Other | 4 states |
| Drug | CLASS II | Loratadine Tablet, 10 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |