CLASS II Drug recall · Reported 27 Mar 2019 · FDA Enforcement Report
Valsartan Tablets USP 160 mg (10 x per Unit Dose Blisters recalled
American Health Packaging is recalling Valsartan Tablets USP 160 mg (10 x per Unit Dose Blisters, distributed nationwide in the US. The recall was initiated on 6 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-1047-2019
- FDA event ID
- 82316
- Recalling firm
- American Health Packaging, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 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
| 6 Mar 2019 | Recall initiated by company | |
| 21 Mar 2019 | Classified by FDA | +15 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 Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
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 USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217 (Individual Dose NDC:60687-139-11, Carton NDC#: 60687-139-01)
Where it was distributed
Nationwide USA and Puerto Rico
Questions about this recall
Why was it recalled?
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Which lots are affected?
Lot 179791, Mar 2020
Where was it sold?
Nationwide USA 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 26 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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