Valganciclovir Hydrochloride for Oral Solution — Class II drug recall D-0518-2020
Terminated recall by Teva Pharmaceuticals USA, Inc., reported 2019-11-27, distributed nationwide. Presence of foreign substance: Brown/black particles found during stability testing.
| Recall number | D-0518-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc., North Wales, PA, United States |
| Recall initiated | 2019-11-04 |
| Classified | 2019-11-21 |
| Reported by FDA | 2019-11-27 |
| Terminated | 2020-11-17 |
| Distributed | Nationwide (US) |
| Quantity | 3,623 bottles |
| Reason classes | specification failure |
| NDC | 00591-2579, 00591-2579-20 |
| Expiration dates | 2020-05 |
Product
Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavis Laboratories FL. Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-2579-20
Reason for recall
Presence of foreign substance: Brown/black particles found during stability testing.
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-0518-2020. 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.