CLASS II Drug recall · Reported 27 Nov 2019 · FDA Enforcement Report
Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL recalled
Teva Pharmaceuticals USA is recalling Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, distributed nationwide in the US. The recall was initiated on 4 Nov 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0518-2020
- FDA event ID
- 84242
- Recalling firm
- Teva Pharmaceuticals USA, North Wales, PA
- Manufacturer
- Actavis Pharma, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Nov 2019
- FDA classified
- 21 Nov 2019
- Reported
- 27 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
Timeline
| 4 Nov 2019 | Recall initiated by company | |
| 21 Nov 2019 | Classified by FDA | +17 days |
| 27 Nov 2019 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign substance: Brown/black particles found during stability testing.
Product as listed by the FDA
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
Where it was distributed
Product was distributed to wholesalers/distributors throughout the United States.
Questions about this recall
Why was it recalled?
Presence of foreign substance: Brown/black particles found during stability testing.
Which lots are affected?
Lot #: CBFCN, CBHFG, Exp 05/2020
Where was it sold?
Product was distributed to wholesalers/distributors throughout the United States.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Valganciclovir recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Valganciclovir Tablets, USP, 450 mg recalledValganciclovir | Hetero Labs Limited Unit V | Temperature Abuse | Nationwide |