FDA Drug recall D-0521-2016
Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICAL I…
- FDA Drug
- Class III
- terminated
- Published 2015-12-23
On 2015-12-23 the FDA classified a Class III recall of Irbesartan and Hydrochlorothiazide tablets USP 150 mg/ 12.5 mg, 90-count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICAL I… by Teva Pharmaceutical Industries, citing labeling: Incorrect or Missing Lot AND/OR Exp Date.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0521-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2015-10-20 |
| Published | 2015-12-23 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceutical Industries |
| Distribution | US |
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
Labeling: Incorrect or Missing Lot AND/OR Exp Date.
Identifiers
| ndc | 0093-8238-56 |
|---|---|
| ndc | 0093-8238-98 |
| ndc | 0093-8232-56 |
| ndc | 0093-8232-98 |
| code_info | Lot #: 24I030, Exp 5/2017 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0521-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.