CLASS II Drug recall · Reported 8 Feb 2023 · FDA Enforcement Report

Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg recalled

SUN Pharmaceutical Industries is recalling Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg, distributed nationwide in the US. The recall was initiated on 13 Jan 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: HAC3120A, HAC3121A, Exp. 04/2023; HAC4460A, Exp. 10/2023; HAD0365A, Exp. 12/2023; HAD1452A, Exp. 02/2024.

NDC47335-675, 47335-676, 47335-677, 47335-678, 47335-679

UPC0347335679830, 0347335677836, 0347335676839, 0347335678833, 0347335675832

Quantity recalledLot # HAC3120A: 6912 Bottles; Lot # HAC3121A: 6792 Bottles; Lot # HAC4460A: 6816 Bottles; Lot # HAD0365A: 6744 Bottles; Lot # HAD1452A: 6840 Bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0262-2023
FDA event ID: 91500
Recalling firm: SUN Pharmaceutical Industries, Princeton, NJ
Brand: Diltiazem Hydrochloride
Manufacturer: Sun Pharmaceutical Industries, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 13 Jan 2023
FDA classified: 2 Feb 2023
Reported: 8 Feb 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Pressure Medication

Timeline

13 Jan 2023	Recall initiated by company
2 Feb 2023	Classified by FDA	+20 days
8 Feb 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

Nationwide in the U.S.

Nationwide

Questions about this recall

Why was it recalled?

Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

Which lots are affected?

Lot #: HAC3120A, HAC3121A, Exp. 04/2023; HAC4460A, Exp. 10/2023; HAD0365A, Exp. 12/2023; HAD1452A, Exp. 02/2024.

Where was it sold?

Nationwide in the U.S.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from SUN Pharmaceutical Industries

All 138

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS II	Carbamazepine Tablets, USP, 200mg recalled	SUN Pharmaceutical Industries	Manufacturing (CGMP) Deviations	Nationwide
8 Jul 2026Drug	CLASS III	Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine recalled	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
1 Jul 2026Drug	CLASS II	Perampanel CIII Tablets, 6mg recalled by Sun Pharmaceutical IndustriesPerampanel	SUN Pharmaceutical Industries	Packaging Defects	Nationwide
17 Jun 2026Drug	CLASS I	DOXOrubin Hydrochloride Liposome injection, 50 mg recalledDoxorubicin Hydrochloride	SUN Pharmaceutical Industries	Particulate Matter	Nationwide
17 Jun 2026Drug	CLASS II	Budesonide Inhalation Suspension, 1mg recalledBudesonide	SUN Pharmaceutical Industries	Particulate Matter	Nationwide

Other Diltiazem recalls

All 36

Reported	Class	Recall	Company	Reason	Where
16 Apr 2025Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules 12HR recalledDiltiazem Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Manufacturing (CGMP) Deviations	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg recalledDiltiazem Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules recalled	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules recalledDiltiazem Hydrochloride	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide
11 Dec 2024Drug	CLASS II	Diltiazem Hydrochloride Extended-Release Capsules recalled	Glenmark Pharmaceuticals Inc., USA	Nitrosamine Impurity	Nationwide