SUN Pharmaceutical Industries recalls

SUN Pharmaceutical Industries has 141 recalls on record with the FDA and USDA, the earliest in 2013 and the latest reported on 14 Oct 2026. 35 are still ongoing. 23 were reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls141since 2013

Last 12 months23reported

Class I32% of total

Ongoing35latest 14 Oct 2026

Recalls per month, last 24 months

click a bar for that month

0Dec '24 0 0 1Mar 2 0 0Jun 1 1 1Sep 0 7 0Dec 2 1 0Mar 3 0 4Jun 2 1 0Sep 3 0

Severity split

Class I 3 2%Class II 91 65%Class III 47 33%

Why sun pharmaceutical industries is recalled

Product types

Brands

By year

20261611%
2025139%
20241813%
20231712%
20222115%
2021139%
202096%
201986%
201875%
2017118%

Ongoing sun pharmaceutical industries recalls

35 active

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Drug	CLASS III	Tretinoin Cream USP, 0.05% tube recalledTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
14 Oct 2026Drug	CLASS III	Tretinoin Cream UPS recalled by SUN Pharmaceutical IndustriesTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
14 Oct 2026Drug	CLASS III	Tretinoin Cream USP, 0.05% tube recalledTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
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

All sun pharmaceutical industries recalls, newest first

141 total

Reported	Class	Recall	Company	Reason	Where
14 Oct 2026Drug	CLASS III	Tretinoin Cream USP, 0.05% tube recalledTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
14 Oct 2026Drug	CLASS III	Tretinoin Cream UPS recalled by SUN Pharmaceutical IndustriesTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
14 Oct 2026Drug	CLASS III	Tretinoin Cream USP, 0.05% tube recalledTretinoin	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
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
10 Jun 2026Drug	CLASS II	Xyvona (levorphanol tartrate tablets), 3mg recalled	SUN Pharmaceutical Industries	Other	Nationwide
10 Jun 2026Drug	CLASS II	Xyvona (levorphanol tartrate tablets), 2mg recalled	SUN Pharmaceutical Industries	Other	Nationwide
22 Apr 2026Drug	CLASS II	Fluocinonide, USP, 0.05% Cream tube recalledFluocinonide	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
22 Apr 2026Drug	CLASS II	Fluocinonide, USP, 0.05% Cream tube recalledFluocinonide	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
22 Apr 2026Drug	CLASS II	Fluocinonide, USP, 0.05% Cream tube recalledFluocinonide	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
11 Feb 2026Drug	CLASS II	Diclofenac Sodium, Topical Gel, 3% tube recalledDiclofenac Sodium	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
21 Jan 2026Drug	CLASS III	Clindamycin Phosphate USP, 1% (10 mg/mL) recalledClindamycin Phosphate	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
21 Jan 2026Drug	CLASS III	Fluocinolone Acetonide Solution Topical Solution recalledFluocinolone Acetonide	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 30 mg, CII recalledLisdexamfetamine Dimesylate	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 40 mg, CII recalledLisdexamfetamine Dimesylate	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 10 mg, CII recalledLisdexamfetamine Dimesylate	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 20 mg, CII recalledLisdexamfetamine Dimesylate	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 70 mg, CII recalledLisdexamfetamine Dimesylate	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 50 mg, CII recalledLisdexamfetamine Dimesylate	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
5 Nov 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 60 mg, CII recalledLisdexamfetamine Dimesylate	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
24 Sep 2025Drug	CLASS II	Kit for the Preparation of Technetium Tc 99m Mertiatide recalledKit For The Preparation Of Technetium Tc99m Mertiatide	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
13 Aug 2025Drug	CLASS II	Spironolactone Tablets, USP, 25 mg recalledSpironolactone	SUN Pharmaceutical Industries	Other	Nationwide
23 Jul 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 60 mg, CII recalledLisdexamfetamine Dimesylate	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
16 Apr 2025Drug	CLASS III	Gabapentin Capsules, USP 300 mg recalledGabapentin	SUN Pharmaceutical Industries	Packaging Defects	Nationwide
16 Apr 2025Drug	CLASS III	Gabapentin Capsules, USP 400 mg recalledGabapentin	SUN Pharmaceutical Industries	Packaging Defects	Nationwide
12 Mar 2025Drug	CLASS II	Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
24 Jul 2024Drug	CLASS II	Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg recalledNitrofurantion	SUN Pharmaceutical Industries	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.