Browse Drug Recalls
515 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 515 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 515 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 2, 2023 | 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJEC... | Presence of Particulate Matter: identified as glass. | Class I | Pfizer Inc. |
| Oct 2, 2023 | 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of U... | Presence of Particulate Matter: identified as glass. | Class I | Pfizer Inc. |
| Sep 28, 2023 | Triamcinolone Acetonide Injectable Suspension, USP, 400 mg per 10 mL (40mg/mL... | Presence of Particulate Matter: A product complaint of a piece of glass was identified in a vial.... | Class II | Eugia US LLC |
| Jul 3, 2023 | Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multipl... | Presence of Particulate Matter: Particulate matter identified as fiber. | Class II | Accord Healthcare, Inc. |
| Jul 3, 2023 | Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured... | Presence of Particulate Matter: Particulate matter identified as fiber. | Class II | Accord Healthcare, Inc. |
| 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. |
| Dec 28, 2022 | Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL V... | Presence of Particulate Matter: Customer complaint of dark particles found inside the vial | Class II | Eugia US LLC |
| Dec 22, 2022 | Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Sing... | Presence of Particulate Matter: Glass particulate matter detected in injectable. | Class I | Pfizer Inc. |
| Dec 8, 2022 | Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/... | Presence of Particulate Matter: Presence of foreign substances were reported in vials at the phar... | Class II | McGuff Compounding Pharmacy Services, Inc. |
| Dec 8, 2022 | Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) In... | Presence of Particulate Matter: Presence of foreign substances were reported in vials at the phar... | Class II | McGuff Compounding Pharmacy Services, Inc. |
| Oct 7, 2022 | Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Sy... | Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe. | Class I | Viatris Inc |
| Sep 27, 2022 | Aminophylline Injection, USP 250 mg/10 mL (25 mg/mL) 25x10 mL Single-dose via... | Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial. | Class II | Pfizer Inc. |
| Sep 26, 2022 | Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx ... | Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate fl... | Class II | AuroMedics Pharma LLC |
| Sep 26, 2022 | Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dos... | Presence of Particulate Matter: Piece of metal found in a vial | Class III | AuroMedics Pharma LLC |
| Sep 21, 2022 | Ampicillin for Injection, USP, 2 grams/vial NDC 67457-352-02, packaged in 10 ... | Presence of Particulate Matter: A complaint was received for the presence of a single strand of h... | Class II | Viatris Inc |
| Aug 22, 2022 | PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass... | Presence of particulate matter | Class I | Pfizer Inc. |
| Jul 13, 2022 | Propofol Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL per g... | Presence of particulate matter: particulate identified as a beetle. | Class I | Pfizer 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 |
| Mar 31, 2022 | Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottl... | Presence of foreign substance: Presence of stainless steel particulates in tablets. | Class II | MERCK SHARP & DOHME CORP |
| Mar 29, 2022 | IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, ... | Presence of Particulate Matter: Product was found to contain silica and iron oxide | Class I | Teva Pharmaceuticals USA Inc |
| Mar 4, 2022 | Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 t... | Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts o... | Class I | Fresenius Kabi USA, LLC |
| Jan 26, 2022 | Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged ... | Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot | Class I | AuroMedics Pharma LLC |
| Dec 3, 2021 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M... | Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of... | Class I | Gilead Sciences, Inc. |
| Oct 19, 2021 | Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx onl... | Presence of Particulate Matter: Identified as Glass Particles | Class I | MERCK SHARP & DOHME CORP |
| Sep 3, 2021 | AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible co... | Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous ... | Class I | ICU Medical Inc |
| Jun 18, 2021 | Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceutical... | Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. ... | Class I | Teva Pharmaceuticals USA |
| 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 3, 2021 | Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx onl... | Presence of Particulate Matter: particulate matter identified as an insect in one vial. | Class II | Pfizer Inc. |
| Mar 9, 2021 | 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manu... | Presence of particulate matter.one confirmed customer report of particulate matter within two se... | Class II | ICU Medical Inc |
| Dec 23, 2020 | Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single ... | Presence of Particulate Matter - found in reserve sample vials at the firm. | Class I | Fresenius Kabi USA, LLC |
| Dec 23, 2020 | Oxycodone Hydrochloride Oral Solution, USP 5 mg/5mL unit dose cups, Rx Only, ... | Presence of Foreign Substance: Particulate matter was found in multiple lots of product. | Class III | Genus Lifesciences Inc. |
| Dec 17, 2020 | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), package... | Presence of Particulate Matter - found in reserve sample vials at the firm. | Class II | Fresenius Kabi USA, LLC |
| Oct 7, 2020 | Bupivacaine Hydrochloride in 8.25% Dextrose Injection, USP Spinal 0.75% (15 m... | Presence of particulate matter in solution - black and transparent particles | Class II | Baxter Healthcare Corporation |
| Jul 7, 2020 | Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Ma... | Presence of Particulate Matter | Class I | Mylan Institutional LLC |
| May 29, 2020 | Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial, Rx Only... | Presence of Particulate Matter: particulate matter identified after reconstitution. | Class II | Pfizer Inc. |
| May 8, 2020 | LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira... | Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matt... | Class I | ICU Medical Inc |
| Apr 23, 2020 | R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride ... | Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac | Class III | QuVa Pharma, Inc. |
| Apr 20, 2020 | Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), package... | Presence of Particulate Matter - found in reserve sample vials at the firm. | Class II | Fresenius Kabi USA, LLC |
| Apr 20, 2020 | Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single ... | Presence of Particulate Matter - found in reserve sample vials at the firm. | Class I | Fresenius Kabi USA, LLC |
| Mar 9, 2020 | Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharma... | Presence of particulate matter. presence of metal particles. | Class II | Mylan Pharmaceuticals Inc. |
| Feb 21, 2020 | Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Manufactured by: A... | Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... | Class III | Akorn, Inc. |
| Feb 21, 2020 | CVS Health Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, Distribu... | Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... | Class III | Akorn, Inc. |
| Feb 21, 2020 | Well at Walgreens Sodium Chloride Ophthalmic Ointment USP, 5%, 3.5 g tubes, D... | Presence of Particulate Matter: Brown spots observed on the inside of the tube of product, identi... | Class III | Akorn, Inc. |
| Dec 27, 2019 | Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repacka... | Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer... | Class I | RemedyRepack Inc. |
| Dec 17, 2019 | Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose ... | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Class I | Hikma Pharmaceuticals USA Inc. |
| Dec 17, 2019 | Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL... | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Class II | Hikma Pharmaceuticals USA Inc. |
| Nov 12, 2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) BUPivacaine HCl 0.0625% 156.25 mg/250 mL (... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | fentaNYL 1500 mcg/30 mL (50 mcg/mL) 30 mL PCA Vial Preservative Free, Rx, QuV... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | fentaNYL 500 mcg/250 mL (2 mcg/mL) Bupivacaine HCl 0.1% 250 mg/250 mL (1 mg/m... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, Inc. |
| Nov 12, 2019 | fentaNYL 200 mcg/100 mL (2 mcg/mL) 0.125% Bupivacaine HCl 125 mg/100 mL (1.25... | Presence of Particulate matter: manufacturer recalled fentanyl API due to potential for glass par... | Class II | QuVa Pharma, 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.