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 |
|---|---|---|---|---|
| Dec 1, 2022 | Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185... | Presence of foreign substance | 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 |
| Jul 25, 2022 | Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in ... | Discoloration | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 27, 2022 | Divalproex Sodium Delayed-Release Tablets, USP 500mg, Rx Only, 100 Tablets, D... | Failed Dissolution Specifications: Failure occurred during routine stability testing of dissoluti... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 21, 2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsu... | Superpotent Drug: Out of specification for assay at the 12-month timepoint. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 21, 2022 | Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-d... | cGMP - Water leakage | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 21, 2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsul... | Superpotent Drug: Out of specification for assay at the 12-month timepoint. | Class III | 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 |
| Jun 3, 2022 | Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose via... | CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of... | 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, 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 |
| Apr 29, 2022 | buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in... | Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance foun... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 29, 2022 | buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count b... | Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance foun... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 1, 2022 | Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 si... | Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for ... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 7, 2022 | Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: ... | Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubrican... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 25, 2021 | Tadalafil Tablets, USP 20 mg, 30 count bottle, Rx Only, Manufactured for: Nor... | Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the pro... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 25, 2021 | Tadalafil Tablets, USP 5 mg, 30 count bottle, Rx Only, Manufactured for: Nort... | Incorrect Product Formulation: An incorrect grade of Crospovidone was used to manufacture the pro... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| 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 |
| Oct 12, 2021 | Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate... | Failed Moisture Limits | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 12, 2021 | AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release... | Failed Moisture Limits | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jul 29, 2021 | Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx L... | Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 7, 2021 | Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouche... | Subpotent and Presence of Particulates . | Class III | 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 31, 2021 | Riomet (metformin hydrochloride oral solution) 500 mg/5 mL Cherry Flavor, 16 ... | Microbial Contamination of Non-Sterile Product | 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 |
| Mar 15, 2021 | Ganirelix Acetate Injection, 250 mcg/0.5 mL, Sterile Prefilled Syringe, Rx on... | Failed Impurities/Degradation Specifications | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Feb 22, 2021 | Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouche... | Subpotent | 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 11, 2021 | Testosterone Cypionate Injection, USP CIII 200mg/ml FOR INTRAMUSCULAR USE ONL... | Incorrect Labeling: Incorrect lot number on secondary packaging | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Sep 23, 2020 | RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500... | CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jul 6, 2020 | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx ... | Cross contamination with other products - OOS discovered during routine stability testing for hig... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Dec 7, 2018 | Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Pa... | Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained dur... | Class III | Sun Pharmaceutical Industries, Inc. |
| Jul 17, 2015 | buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-... | Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it... | Class III | Sun Pharma Global Fze |
| May 21, 2013 | Nimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count u... | Crystallization; crystallized nimodipine | 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.