Browse Drug Recalls

89 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 89 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 89 FDA drug recalls.

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DateProductReasonClassFirm
Jan 27, 2026 Diclofenac Sodium, Topical Gel, 3%, 100 g tube, Rx only, Mfd. by: Taro Pharma... Failed Viscosity Specifications: Out of Specification (OOS) [slightly lower than the limit] resul... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Dec 30, 2025 Fluocinolone Acetonide Solution Topical Solution USP, 0.01%, 60-mL bottles, R... Failed Impurities/Degradation Specifications: Out of specification result was obtained for the kn... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Nov 26, 2025 Clindamycin Phosphate USP, 1% (10 mg/mL), Topical Solution, 60 mL per applica... Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. Class III SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 30 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 10 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 20 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 70 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 50 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 28, 2025 Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottle, Rx only, ... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Sep 3, 2025 Kit for the Preparation of Technetium Tc 99m Mertiatide, Rx Only, Manufacture... Failed Dissolution Specifications-Out of Specification (OOS) observation for sulphate in Sodium T... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Aug 5, 2025 Spironolactone Tablets, USP, 25 mg, 100-count bottle, Rx only, Mfg. by: Front... Presence of foreign substance: identified as aluminum. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 16, 2025 Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only,... Failed Dissolution Specifications: An out of specification results observed in dissolution test d... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 4, 2025 Gabapentin Capsules, USP 300 mg, Rx Only, Packaged in a) 500-count bottles, ... Cross Contamination Class III SUN PHARMACEUTICAL INDUSTRIES INC
Mar 4, 2025 Gabapentin Capsules, USP 400 mg, Rx Only, Packaged in a) 500-count bottles, N... Cross Contamination Class III SUN PHARMACEUTICAL INDUSTRIES INC
Feb 6, 2025 Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only... Failed Dissolution Specifications Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jul 9, 2024 Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules p... Failed Dissolution Specifications Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jul 2, 2024 Decitabine for Injection 50mg per vial, For intravenous infusion only Cytotox... CGMP Deviations: Out of Specification for Total Aerobic Microbial Count (TAMC) test for unfiltere... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Apr 22, 2024 Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle... Failed Release Testing: Out of specification for particulate matter test. Class III SUN PHARMACEUTICAL INDUSTRIES INC
Apr 19, 2024 Amphotericin B Liposome for Injection, 50mg vials, Rx only, Distributed by: S... Out of specification for assay Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 4, 2024 Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 4, 2024 Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufact... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Feb 5, 2024 Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bo... Failed Dissolution Specifications: Out of specification for dissolution. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hou... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, D... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distr... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablet... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets ... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jan 18, 2024 Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distri... CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufa... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Dec 4, 2023 Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distribute... Failed Impurities/Degradation Specifications Class II SUN PHARMACEUTICAL INDUSTRIES INC
Nov 22, 2023 buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets... Failed Dissolution Specifications Class III SUN PHARMACEUTICAL INDUSTRIES INC
Oct 20, 2023 Liothyronine Sodium Tablets, USP, 25 mcg, 100-count bottles, Rx only, Distrib... Failed Impurities/Degradation Specifications. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 20, 2023 Liothyronine Sodium Tablets, USP, 5 mcg, 100-count bottles, Rx only, Distribu... Failed Impurities/Degradation Specifications. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 4, 2023 Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets... Failed Dissolution Specifications Class III SUN PHARMACEUTICAL INDUSTRIES INC
Sep 7, 2023 Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouche... Subpotent: Out of Specification result observed for low assay Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jul 18, 2023 Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured b... Out of Specification result observed in content uniformity testing Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jul 13, 2023 Methylphenidate Hydrochloride Tablets, USP 20mg, Rx Only, 100 Tablets per bot... Presence of Foreign Substance: Metal embedded in a tablet. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jul 10, 2023 Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Ph... Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jul 5, 2023 Loteprednol Etabonate Ophthalmic Suspension, 5 mg/mL (0.5%), packaged as one ... Superpotent Drug: Out of Specification (OOS) results observed for unit dose content. Class III SUN PHARMACEUTICAL INDUSTRIES INC
May 30, 2023 Amphotericin B Liposome for Injection, 50mg/vial, Rx only, Distributed by Sun... Subpotent drug Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 9, 2023 buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablet... Failed Dissolution Specifications; during stability testing Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 3, 2023 Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactur... CGMP Deviations Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 29, 2023 Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-d... Failed Impurities/Degradation Specifications: Above the specification limits yielded for related ... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Mar 9, 2023 Dofetilide Capsules, 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured... Failed Content Uniformity Specifications Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jan 13, 2023 Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-c... Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and fai... Class II SUN PHARMACEUTICAL INDUSTRIES INC

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.