Loratadine-D Extended-Release Tablets — Class III drug recall D-0068-2022
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2021-11-03, distributed nationwide. Failed Moisture Limits
| Recall number | D-0068-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2021-10-12 |
| Classified | 2021-10-26 |
| Reported by FDA | 2021-11-03 |
| Terminated | 2023-08-31 |
| Distributed | Nationwide (US) |
| Quantity | 22,752 blister |
| NDC | 00904-5833, 00904-5833-15, 00904-5833-48 |
| Lot numbers | AC14635 |
| Expiration dates | 2022-12 |
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 for recall
Failed Moisture Limits
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0068-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.