Class II · Moderate risk
Diovan (valsartan)
Failed Dissolution Specifications
Valsartan Tablets USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Incorrect/Undeclared Excipient: There is a potential an incorrect grade of excipient was used during manufacturing.
Cause type: Chemical / undeclared
A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.
What was recalled
Valsartan Tablets USP, 160 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd Roorkee 0247661 India, Marketed by: Jubilant Cardista Pharmaceuticals Inc. Salisbury, MD 21801, USA, NDC 59746-362-90
Affected NDC
59746-0362-90
Compare with the code on your package — it is the most precise check available.
Drug: Valsartan Category: Blood Pressure Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| valsartan NDC 59746-0362 |
160 mg/1 | Tablet Oral |
Jubilant Cadista Pharmaceuticals Inc. | Rx |
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- NDC code
- 59746-362-90
- Origin
- MD, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1105-2018 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Valsartan recalls
See all
Class II · Moderate risk
Valsartan Tablets USP 40 mg 30 Scored Tablets Rx Only NDC…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Valsartan Tablets 320 mg USP
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk
Valsartan Tablets 160 mg USP
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Class II · Moderate risk
Valsartan Tablets 80 mg USP
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Other recalls by Jubilant Cadista Pharmaceuticals, Inc.
All 2018 recalls
Class III · Low risk
Prochlorperazine Maleate Tablets
Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
Class II · Moderate risk
Irbesartan Tablets
Failed Dissolution Specifications
Class II · Moderate risk
Irbesartan Tablets
Failed dissolution specifications.
Class III · Low risk
Methylprednisolone Tablets
Subpotent
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.