Browse Drug Recalls
28 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 28 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 28 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 | 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 | 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 |
| 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 |
| Jun 16, 2023 | Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx onl... | Packaging defect: blister packaging inadequately sealed. | Class II | The Harvard Drug Group |
| Apr 19, 2023 | Fyremadel (ganirelix acetate) injection, 250 mcg/0.5 mL, One Single Dose Ster... | Presence of Particulate Matter: A piece of glass was found in a prefilled syringe. | Class II | Sun Pharmaceutical Industries Ltd. |
| 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 |
| Oct 18, 2022 | Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx... | Presence of Foreign Substance | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 10, 2022 | Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per c... | Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial exc... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 3, 2022 | Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, ... | Failed Tablet/Capsule Specification; oversized tablet found in a bottle | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 3, 2022 | Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per c... | CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rej... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 6, 2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Single-Dose Vial... | Lack of assurance of sterility | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 6, 2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syring... | Lack of assurance of sterility | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 6, 2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 25 x 1 mL Single-Dose... | Lack of assurance of sterility | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 6, 2022 | medroxyPROGESTERone Acetate Injectable Suspension, USP, 1 mL Prefilled Syring... | Lack of assurance of sterility | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 28, 2022 | PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 ... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| Oct 22, 2021 | Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Ph... | Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 4, 2021 | Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bo... | Presence of foreign substance: identified as activated carbon. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 25, 2021 | Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottl... | Failed Moisture Limits: Out of specification for water content | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 5, 2021 | Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distribute... | Failed Impurity/Degradation Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jan 3, 2019 | Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL L... | Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromid... | Class I | Sun Pharmaceutical Industries, Inc. |
| Jan 3, 2019 | Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL ... | Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromid... | Class I | Sun Pharmaceutical Industries, Inc. |
| Jul 3, 2018 | Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a ... | Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, ... | 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.