Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12 — Class III drug recall D-0521-2016
Terminated recall by Teva Pharmaceutical Industries, reported 2015-12-23, distributed nationwide. Labeling: Incorrect or Missing Lot AND/OR Exp Date.
| Recall number | D-0521-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceutical Industries, Jerusalem, N/A, Israel |
| Recall initiated | 2015-10-20 |
| Classified | 2015-12-17 |
| Reported by FDA | 2015-12-23 |
| Terminated | 2016-11-01 |
| Distributed | Nationwide (US) |
| Quantity | 3,536 bottles |
| Reason classes | labeling |
| NDC | 00093-8232, 00093-8232-56, 00093-8232-98, 00093-8238, 00093-8238-56, 00093-8238-98 |
| Lot numbers | 24I030 |
| Expiration dates | 2017-05 |
Product
Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICAL INDUSTRIES LTD Jerusalem, 971010 Israel, Manufactured for: TEVA PHARMACEUTICAL INDUSTRIES USA Sellersville, PA 18960. NDC 0093-8238-98
Reason for recall
Labeling: Incorrect or Missing Lot AND/OR Exp Date.
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-0521-2016. 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.