CLASS II Drug recall · Reported 12 Sep 2018 · FDA Enforcement Report
Valsartan and Hydrochlorothiazide 80 mg/12 recalled
Avkare Incorporated is recalling AvKARE Valsartan and Hydrochlorothiazide 80 mg/12, distributed nationwide in the US. The recall was initiated on 18 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-1173-2018
- FDA event ID
- 80940
- Recalling firm
- Avkare Incorporated, Pulaski, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 18 Jul 2018
- FDA classified
- 6 Sep 2018
- Reported
- 12 Sep 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 18 Jul 2018 | Recall initiated by company | |
| 6 Sep 2018 | Classified by FDA | +50 days |
| 12 Sep 2018 | 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: 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
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90
Where it was distributed
Nationwide
Questions about this recall
Is Valsartan and Hydrochlorothiazide 80 mg/12 recalled?
Yes. Avkare Incorporated recalled Valsartan and Hydrochlorothiazide 80 mg/12 on 18 Jul 2018. The recall is Class II and its status is Terminated. Recall number D-1173-2018.
Why was it recalled?
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Which lots are affected?
Lots: 17349 Exp. 08/2018; 18395 Exp. 08/2018; 19221 Exp. 06/2019; 20029 Exp. 06/2019; 20158 Exp. 07/2019; 20843 Exp. 07/2019; 21411 Exp. 09/2019.
Where was it sold?
Nationwide
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 Avkare Incorporated
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Valsartan and Hydrochlorothiazide 320 mg recalled by Avkare Incorporated | Avkare Incorporated | Potency & Assay | Nationwide |
| Drug | CLASS II | Valsartan and Hydrochlorothiazide 160 mg/12 recalled | Avkare Incorporated | Potency & Assay | Nationwide |
| Drug | CLASS II | Valsartan and Hydrochlorothiazide 160 mg recalled by Avkare Incorporated | Avkare Incorporated | Potency & Assay | Nationwide |
| Drug | CLASS II | Valsartan and Hydrochlorothiazide 320 mg/12 recalled | Avkare Incorporated | Potency & Assay | Nationwide |