Food, drugs, devices › Teva Pharmaceuticals USA, Inc.
Drug recall: Valganciclovir Hydrochloride for Oral Solution, 50 mg/mL, 100 mL (3.4 fl. oz.) bottle, Rx only, Manufactured for: Actavi
FDA enforcement event 84242 is a drug recall by Teva Pharmaceuticals USA, Inc. of North Wales, PA, initiated 4 Nov 2019 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 68% of the 362 drug enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 17 Nov 2020. Initiation: voluntary: firm initiated. Teva Pharmaceuticals USA, Inc. has 60 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Teva Pharmaceuticals USA, Inc., North Wales, PA.
Reason for recall
"Presence of foreign substance: Brown/black particles found during stability testing."
Distribution
"Product was distributed to wholesalers/distributors throughout the United States."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0518-2020 | 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 | 3,623 bottles | Class II | Terminated | 27 Nov 2019 |
Context
Other enforcement events for Teva Pharmaceuticals USA, Inc.
All 60 events for Teva Pharmaceuticals USA, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Presence of foreign substance: Brown/black particles found during stability testing."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed to wholesalers/distributors throughout the United States."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 17 Nov 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.