Amlodipine and Valsartan Tablets 5 mg/160 mg — Class II drug recall D-0303-2019
Ongoing recall by Teva Pharmaceuticals USA, reported 2018-12-19, distributed nationwide. CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in pr
| Recall number | D-0303-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2018-11-27 |
| Classified | 2018-12-14 |
| Reported by FDA | 2018-12-19 |
| Distributed | Nationwide (US) |
| Quantity | 120,394 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 00093-7690-56, 00093-7690-98 |
| Lot numbers | 23X017, 23X018, 23X019, 23X020, 23X022, 23X023, 23X024 |
Product
Amlodipine and Valsartan Tablets 5 mg/160 mg, (a) 30-count bottles (NDC 0093-7690-56) & 90-count bottles (NDC 0093-7690-98), RX Only, Manufactured In Israel By: TEVA PHARMACEUTICAL IND. LTD. Jerusalem, 9777402, Israel, Manufactured For: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454.
Reason for recall
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0303-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.