FDA Drug recall D-1206-2018
Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703
- FDA Drug
- Class I
- terminated
- Published 2018-09-19
On 2018-09-19 the FDA classified a Class I recall of Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 by Accord Healthcare, citing product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1206-2018 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2018-08-21 |
| Published | 2018-09-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Accord Healthcare |
| Distribution | US |
Product
Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703; Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, India; NDC 16729-182-01.
Reason
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
Identifiers
| ndc | 16729-183-01 |
|---|---|
| ndc | 16729-183-17 |
| ndc | 16729-182-01 |
| ndc | 16729-182-17 |
| ndc | 16729-184-01 |
| ndc | 16729-184-17 |
| code_info | Lot: PW05264, Exp. 11/2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1206-2018%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.