Valsartan Tablets Recalled Due to Carcinogenic Impurity
American Health Packaging is recalling Valsartan Tablets 160 mg because a carcinogenic impurity was detected in the active ingredient.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of a carcinogenic impurity (NDEA) in a prescription medication represents a significant health risk, aligning with the 'Severe' criteria for significant injury or high-risk contamination.
Plain-English summary
American Health Packaging is recalling Valsartan Tablets USP 160 mg, packaged in unit dose blisters. The recall involves 3,337 cartons of the medication, which was distributed nationwide in the United States and in Puerto Rico.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation. Specifically, N-Nitrosodimethylamine (NDEA), a known carcinogenic impurity, was detected in the active ingredient of the tablets. The affected product is identified by Lot 179791, with a date code of March 2020.
Consumers and healthcare providers should check their inventory for this specific lot number and stop using the product if it matches the description. Patients should consult their healthcare provider for alternative treatment options or further instructions regarding this recall.
The recalled product
- Product
- 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)
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 3,337
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 179791
- Mar 2020
Distribution
Related recalls
Same manufacturer · American Health Packaging
See all →- LowBuprenorphine Sublingual Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-09-09
- ModerateNitrofurantoin Capsules 100 mg recalled for failed dissolution specifications
FDA (Drugs) · 2022-05-25
- ModerateCyanocobalamin Injection Recalled Due to Subpotency and Assay Non-Compliance
FDA (Drugs) · 2022-05-04
- SevereOxycodone Hydrochloride Oral Solution Recall Due to Impurity Failure
FDA (Drugs) · 2022-03-16
- ModerateMetoprolol Succinate ER Tablets Recall for Failed Dissolution
FDA (Drugs) · 2022-02-02
Same hazard · carcinogen
See all →- SevereFDA Recalls Mirabegron Tablets Over Nitrosamine Impurity
FDA (Drugs) · 2026-08-12
- SevereTinactin Tolnaftate Deodorant Powder Spray Recalled for Benzene Contamination
FDA (Drugs) · 2021-11-24
- SevereCoppertone SPORT Sunscreen Spray recalled for benzene contamination
FDA (Drugs) · 2021-10-27
- SevereNeutrogena Beach Defense Sunscreen Spray Recalled for Benzene Contamination
FDA (Drugs) · 2021-10-06
- SeverePD-Rx Recalls Losartan Potassium Tablets Due to Trace NMBA Contamination
FDA (Drugs) · 2021-05-05
Similar recalls
- SevereAurobindo Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity
FDA (Drugs) · 2018-09-05
- SevereAurobindo Pharma Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2019-03-27
- SevereAvKARE Recalls Valsartan Tablets Due to Carcinogen Impurity in API
FDA (Drugs) · 2018-09-05
- SevereMylan Recalls Valsartan Tablets Due to NDEA Impurity
FDA (Drugs) · 2018-12-19
- SevereMajor Pharmaceuticals Recalls Valsartan Tablets Due to Carcinogen Impurity
FDA (Drugs) · 2018-08-01