Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 1, 2019 | Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-3... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) ... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)9... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | Dr. Reddy's Laboratories, Inc. |
| Oct 1, 2019 | Testosterone Cypionate 180 mg/mL/Testosterone Propionate 20mg/mL Oil Injectio... | Lack of sterility assurance. | Class II | New Vitalis Pharmacy LLC dba New Vitalis Pharmacy |
| Sep 27, 2019 | Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-... | Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert... | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Sep 27, 2019 | Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-... | Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert... | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Sep 27, 2019 | Ibuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manu... | Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert... | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Sep 27, 2019 | Children's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-... | Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert... | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Sep 27, 2019 | Ibuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Man... | Presence of Foreign Substance: Ibuprofen Oral Suspension USP may have small particles of an inert... | Class II | Taro Pharmaceuticals U.S.A., Inc. |
| Sep 26, 2019 | Estradiol tablets, 0.5 mg, 100-count bottles, Rx only, Distributed by Epic P... | Presence of Foreign Tablets/Capsules: Estradiol 1 mg was found in a 100 count bottle of Estradiol... | Class II | Epic Pharma, LLC |
| Sep 26, 2019 | Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial.... | Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed ... | Class II | Alkermes, Inc. |
| Sep 24, 2019 | Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Table... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Class II | Apotex Inc. |
| Sep 24, 2019 | Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Class II | Apotex Inc. |
| Sep 24, 2019 | Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint A... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Class II | Apotex Inc. |
| Sep 24, 2019 | Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reduce... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Class II | Apotex Inc. |
| Sep 24, 2019 | Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Redu... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Class II | Apotex Inc. |
| Sep 24, 2019 | Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Re... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Class II | Apotex Inc. |
| Sep 23, 2019 | Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactur... | CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (N... | Class II | Sandoz, Inc |
| Sep 23, 2019 | DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measu... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| Sep 23, 2019 | DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| Sep 23, 2019 | Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactur... | CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (N... | Class II | Sandoz, Inc |
| Sep 23, 2019 | Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactu... | CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (N... | Class II | Sandoz, Inc |
| Sep 23, 2019 | Prednisolone Sodium Phosphate Oral Solution, 15 mg/5 mL, packaged in a 8 fl o... | Failed Impurities/Degradation Specifications - failed specs for Prednisolone Impurity 14 | Class II | Morton Grove Pharmaceuticals, Inc. |
| Sep 23, 2019 | Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manu... | Superpotent | Class II | Macleods Pharma Usa Inc |
| Sep 20, 2019 | Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx ... | Lack of Assurance of Sterility: Out of specification results for container closure test which can... | Class II | Akorn, Inc. |
| Sep 19, 2019 | Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets ... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 19, 2019 | Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manuf... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 19, 2019 | Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx O... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 19, 2019 | Losartan Potassium/ Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 tablets p... | CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... | Class II | Torrent Pharma Inc. |
| Sep 19, 2019 | Dextroamphetamine Sacharate, Amphetamine Aspartate, Dextroamphetamine Sulfate... | Superpotent Drug: Amphetamine Mixed Salts 20mg have been found to be out of specification for wei... | Class II | Aurobindo Pharma USA Inc. |
| Sep 18, 2019 | Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30... | Microbial Contamination of Non-Sterile Product. | Class II | GCP Laboratories Inc |
| Sep 18, 2019 | Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: ... | Lack of sterility assurance. | Class II | Avella of Deer Valley, Inc. Store 38 |
| Sep 17, 2019 | Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufac... | cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tub... | Class II | Akorn, Inc. |
| Sep 13, 2019 | Optiray 320 (ioversol) Injection 68%, 320 mg/mL Organically Bound Iodine, pac... | Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syring... | Class II | GUERBET LLC |
| Sep 12, 2019 | Vitamin 5 B, 30 mL Vial For IM Use, Rx Only, KRS Global Biotechnology 791 Par... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | SUCCinylcholine Chloride (PF), 100 mg / 5 mL (20 mg/mL), 5 mL Fill in a 6 mL ... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | SUCCinylcholine Chloride (PF), 140 mg/7 mL (20 mg/mL), 7 mL Fill in a 12 mL S... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | ePHEDrine Sulfate in 0.9% Sodium Chloride (PF), 50 mg/5 mL (10 mg/mL) 5 mL Fi... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Sermorelin Acetate 9 mg/ 3 mL (3 mg/mL),Rx Only, KRS Global Biotechnology 791... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Sermorelin Acetate, 9 mg / GHRP-2, 5.4 mg/vial Lyophilized-for SC Use, Rx Onl... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | LIDOcaine 2% (20 mg/mL)/Bupivacaine 0.375% (3.75 mg/mL)/ Hyaluronidase 3 U/mL... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Moxifloxacin 0.1% in BSS, Ophthalmic Injection, 0.3 mg/0.3 mL, 0.3 mL Fill in... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | PHENYLephrine HCl in 0.9% Sodium Chloride (PF), 1 mg / 10 mL (0.1 mg/mL), 10 ... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Sermorelin Acetate, 3 mg/mL/GHRP6, 1.8 mg/mL/GHRP2, 1.8 mg/mL, 3 mL Injection... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Lidocaine HCl 30 mg/mL/Hyaluronidase 15 Units/mL (PF) 5 mL Fill in a 6 mL Sin... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, Inc |
| Sep 12, 2019 | Sermorelin Acetate 9 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global B... | Lack of Assurance of Sterility | Class II | KRS Global Biotechnology, 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.