CLASS II Drug recall · Reported 8 Aug 2018 · FDA Enforcement Report
Valsartan tablets 160 mg recalled by H J Harkins Company
H J Harkins Company is recalling Valsartan tablets 160 mg. The recall was initiated on 26 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-1022-2018
- FDA event ID
- 80674
- Recalling firm
- H J Harkins Company, Grover Beach, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 26 Jul 2018
- FDA classified
- 1 Aug 2018
- Reported
- 8 Aug 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 26 Jul 2018 | Recall initiated by company | |
| 1 Aug 2018 | Classified by FDA | +6 days |
| 8 Aug 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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 160 mg, 90-count bottle, Rx Only, Repackaged by H.J. Harkins Co, Inc. Grover Beach, CA 93433, NDC 43547-0369-09. Tablet is yellow, capsule-shaped, biconvex, film-coated tablets debossed with 343 on one side and HH on the other side.
Where it was distributed
Product was distributed to a physician's office.
Questions about this recall
Is Valsartan tablets 160 mg recalled?
Yes. H J Harkins Company recalled Valsartan tablets 160 mg on 26 Jul 2018. The recall is Class II and its status is Terminated. Recall number D-1022-2018.
Why was it recalled?
Carcinogen impurity detected in API used to manufacture drug product.
Which lots are affected?
Lot # VSA000OV Manufacturer's original lot # 343B17015, exp date 02/19 NDC 43547-0369-09
Where was it sold?
Product was distributed to a physician's office.
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 H J Harkins Company
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|---|---|---|---|---|---|
| Drug | CLASS II | Acetaminophen and Codeine Phosphate recalled by H J Harkins Company | H J Harkins Company | Manufacturing (CGMP) Deviations | AZ, CA |
| Drug | CLASS II | Acetaminophen 500 mg tablet packaged in a) 30-count bottles recalled | H J Harkins Company | Packaging Defects | Nationwide |
| Drug | CLASS II | Ranitidine, a), b), c), d), e) recalled by H J Harkins Company | H J Harkins Company | Nitrosamine Impurity | 4 states |
| Drug | CLASS II | Neomycin 5 mg/g / Polymyxin B10000 USP Units/g recalled | H J Harkins Company | Manufacturing (CGMP) Deviations | CA |
| Drug | CLASS II | Diphenhydramine HCL Liquid, 5 mg recalled by H J Harkins Company | H J Harkins Company | Sterility | 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 |