Doxycycline Hyclate Tablets — Class II drug recall D-1288-2020
Terminated recall by The Harvard Drug Group, reported 2020-06-10, distributed nationwide. Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded
| Recall number | D-1288-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | The Harvard Drug Group, Livonia, MI, United States |
| Recall initiated | 2020-05-22 |
| Classified | 2020-06-04 |
| Reported by FDA | 2020-06-10 |
| Terminated | 2022-10-02 |
| Distributed | Nationwide (US) |
| Quantity | 16,443 cartons |
| Reason classes | specification failure |
| NDC | 00904-0430, 00904-0430-04, 00904-0430-06, 00904-0430-95 |
| Expiration dates | 2020-05, 2020-06, 2020-08 |
Product
Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152.
Reason for recall
Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
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-1288-2020. 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.