Diltiazem Hydrochloride Extended-Release Capsules — Class II drug recall D-0262-2023
Terminated recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2023-02-08, distributed nationwide. Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissoluti
| Recall number | D-0262-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2023-01-13 |
| Classified | 2023-02-02 |
| Reported by FDA | 2023-02-08 |
| Terminated | 2023-10-27 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 47335-0675, 47335-0675-13, 47335-0675-18, 47335-0675-19, 47335-0675-81, 47335-0675-83, 47335-0676, 47335-0676-13, 47335-0676-18, 47335-0676-19, 47335-0676-81, 47335-0676-83, 47335-0677, 47335-0677-13, 47335-0677-18, 47335-0677-19, 47335-0677-81, 47335-0677-83, 47335-0678, 47335-0678-13, 47335-0678-18, 47335-0678-19, 47335-0678-81, 47335-0678-83, 47335-0679 and 5 more |
| Lot numbers | HAC3120A, HAC3121A, HAC4460A, HAD0365A, HAD1452A |
| Expiration dates | 2023-04, 2023-10, 2023-12, 2024-02 |
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 for recall
Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
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-0262-2023. 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.