Doxycycline Hyclate Tablets — Class II drug recall D-0014-2026
Ongoing recall by Acella Pharmaceuticals, LLC, reported 2025-10-15, distributed nationwide. Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specification
| Recall number | D-0014-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Acella Pharmaceuticals, LLC, Alpharetta, GA, United States |
| Recall initiated | 2025-09-29 |
| Classified | 2025-10-09 |
| Reported by FDA | 2025-10-15 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 42192-0501, 42192-0501-05, 42192-0501-50 |
| Lot numbers | P24ZLK1 |
| Expiration dates | 2027-05-31 |
Product
Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.
Reason for recall
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
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-0014-2026. 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.