FDA Drug recall D-0068-2022
Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister…
- FDA Drug
- Class III
- terminated
- Published 2021-11-03
On 2021-11-03 the FDA classified a Class III recall of Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister… by Sun Pharmaceutical Industries, citing failed Moisture Limits.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0068-2022 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2021-10-12 |
| Published | 2021-11-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
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
Reason
Failed Moisture Limits
Identifiers
| ndc | 0904-5833-15 |
|---|---|
| ndc | 0904-5833-48 |
| code_info | Lot #: AC14635, Exp. Date 12/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0068-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.