FDA Drug recall D-0262-2023
Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg
- FDA Drug
- Class II
- terminated
- Published 2023-02-08
On 2023-02-08 the FDA classified a Class II recall of Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg by Sun Pharmaceutical Industries, citing failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0262-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-01-13 |
| Published | 2023-02-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 47335-679-81
Reason
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Identifiers
| ndc | 47335-675-83 |
|---|---|
| ndc | 47335-675-81 |
| ndc | 47335-675-19 |
| ndc | 47335-675-13 |
| ndc | 47335-675-18 |
| ndc | 47335-676-83 |
| ndc | 47335-676-81 |
| ndc | 47335-676-19 |
| ndc | 47335-676-13 |
| ndc | 47335-676-18 |
| ndc | 47335-677-83 |
| ndc | 47335-677-81 |
| ndc | 47335-677-19 |
| ndc | 47335-677-13 |
| ndc | 47335-677-18 |
| ndc | 47335-678-83 |
| ndc | 47335-678-81 |
| ndc | 47335-678-19 |
| ndc | 47335-678-13 |
| ndc | 47335-678-18 |
| ndc | 47335-679-83 |
| ndc | 47335-679-81 |
| ndc | 47335-679-19 |
| ndc | 47335-679-13 |
| ndc | 47335-679-18 |
| code_info | Lot #: HAC3120A, HAC3121A, Exp. 04/2023; HAC4460A, Exp. 10/2023; HAD0365A, Exp. 12/2023; HAD1452A, Exp. 02/2024. |
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-0262-2023%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.