CLASS II ONGOING Drug recall · Reported 1 Aug 2018 · FDA Enforcement Report
Valsartan Tablets, USP 40 mg bottle recalled by Teva Pharmaceuticals U
Teva Pharmaceuticals U is recalling Valsartan Tablets, USP 40 mg bottle (, distributed nationwide in the US. The recall was initiated on 16 Jul 2018 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-0986-2018
- FDA event ID
- 80538
- Recalling firm
- Teva Pharmaceuticals U, North Wales, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jul 2018
- FDA classified
- 24 Jul 2018
- Reported
- 1 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 16 Jul 2018 | Recall initiated by company | |
| 24 Jul 2018 | Classified by FDA | +8 days |
| 1 Aug 2018 | Published in enforcement report | +8 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: Carcinogen impurity detected in API used to manufacture drug product.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
Where it was distributed
Product was distributed throughout the United States, including Hawaii and Puerto Rico
Questions about this recall
Is Valsartan Tablets, USP 40 mg bottle ( recalled?
Yes. Teva Pharmaceuticals U recalled Valsartan Tablets, USP 40 mg bottle ( on 16 Jul 2018. The recall is Class II and its status is Ongoing. Recall number D-0986-2018.
Why was it recalled?
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Which lots are affected?
Lot Numbers: NDC 0591-2167-30 1196936A, 1238463A, 1270617A NDC 0591-2167-19 1196934M, 1238462M, 1268429A
Where was it sold?
Product was distributed throughout the United States, including Hawaii and Puerto Rico
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.
More recalls from Teva Pharmaceuticals U
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|---|---|---|---|---|---|
| Drug | CLASS II | Tretinoin Capsules, 10 mg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxylamine Succinate and Pyridoxine Hydrochloride recalledDoxylamine Succinate And Pyridoxine Hydrochloride | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS III | Mimvey (estradiol and norethindrone acetate tablets USP) recalledMimvey | Teva Pharmaceuticals U | Labeling Errors | Nationwide |
| Drug | CLASS III | Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg recalledMimvey | Teva Pharmaceuticals U | Labeling Errors | Nationwide |
| Drug | CLASS II | Brinzolamide Ophthalmic Suspension recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Packaging Defects | Nationwide |
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 |