CLASS II ONGOING Drug recall · Reported 27 Mar 2019 · FDA Enforcement Report
Valsartan Tablets 40 mg USP, Rx, Only recalled by Rising Pharmaceuticals
Rising Pharmaceuticals is recalling Valsartan Tablets 40 mg USP, Rx, Only, distributed nationwide in the US. The recall was initiated on 7 Mar 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-1052-2019
- FDA event ID
- 82337
- Recalling firm
- Rising Pharmaceuticals, Saddle Brook, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 7 Mar 2019
- FDA classified
- 21 Mar 2019
- Reported
- 27 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 7 Mar 2019 | Recall initiated by company | |
| 21 Mar 2019 | Classified by FDA | +14 days |
| 27 Mar 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
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ ---- NDC 52343-122-30
Where it was distributed
Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
Questions about this recall
Is Valsartan Tablets 40 mg USP, Rx, Only recalled?
Yes. Rising Pharmaceuticals recalled Valsartan Tablets 40 mg USP, Rx, Only on 7 Mar 2019. The recall is Class II and its status is Ongoing. Recall number D-1052-2019.
Why was it recalled?
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Which lots are affected?
470170038A, exp. date 10/31/2019 470180010A, exp. date 02/29/2019 470180012A, exp. date 03/31/2020
Where was it sold?
Product was distributed to 6 major distributors who may have further distributed the product 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 21 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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|---|---|---|---|---|---|
| Drug | CLASS II | Warfarin Sodium Tablets, USP 1 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Potency & Assay | Nationwide |
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| Drug | CLASS III | Timolol Maleate Sterile Opthalmic Solution recalledTimolol Maleate | Rising Pharmaceuticals | Sterility | Nationwide |
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Other Valsartan recalls
All 66| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diovan (valsartan) 160 mg recalled by Novartis PharmaceuticalsDiovan | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Valsartan Tablets recalled by Cardinal HealthValsartan | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Valsartan Tablets 160 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan Tablets USP 80 mg recalled by Aurobindo Pharma USAValsartan | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Valsartan Tablets USP 320 mg recalled by Aurobindo Pharma USAValsartan | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |