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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.