Browse Drug Recalls
17,625 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,625 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 17,625 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 15, 2023 | Ampicillin and Sulbactam for Injection, USP 1.5 gram per vial, Rx only, Manuf... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin for Injection, USP 500 mg per vial, Rx only, Mfg. for: Piramal Cri... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ceftriaxone for Injection, USP 10 grams per Pharmacy Bulk Package, Mfg. for: ... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin for Injection, USP 10 grams per Pharmacy Bulk Package, Rx only, Ma... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ceftriaxone for Injection, USP 500 mg per vial, Rx only, Manufactured for: Xe... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin and Sulbactam for Injection, USP 15 grams per Pharmacy Bulk Packag... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin and Sulbactam for Injection, USP 3 grams per vial, Rx only, Manufa... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin and Sulbactam for Injection, USP 1.5 grams per vial, Rx only, Manu... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Cefepime for Injection, USP 2 grams per vial, Rx only, Mfg. for: Piramal Crit... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Piperacillin and Tazobactam for Injection, USP, 2.25 grams per vial, Rx only,... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ceftriaxone for Injection, USP 250 mg per vial, Rx only, Mfg. for: Piramal Cr... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, Rx only,... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin for Injection, USP, 250 mg per vial, Rx only, Manufactured for: Xe... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 15, 2023 | Ampicillin for Injection, USP 1g per vial, Rx only, Mfg. for: Piramal Critica... | Lack of Assurance of Sterility | Class II | Astral SteriTech Private Ltd. |
| May 12, 2023 | ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple... | Mislabeling: preservative free product labeled as preserved. | Class II | Empower Clinic Services LLC dba Empower Pharmacy |
| May 11, 2023 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial (NDC 0641-6044-01), packaged in 2... | Failed Impurities/Degradation Specifications: Out-of-specification results for total related comp... | Class II | Hikma Pharmaceuticals USA Inc. |
| May 11, 2023 | Tirzepatide 10 mg/0.5 mL Sterile Solution-2 mL Vial, Rx Only, For Sub-Q Use O... | Sub-potent Drug | Class II | Revive Rx LLC dba Revive Rx Pharmacy |
| 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 9, 2023 | Heparin Sodium, 25,000 USP units per 250mL, (100 USP units per mL) in 5% Dext... | Subpotent: Low anti-factor IIa Potency. | Class II | B. Braun Medical Inc |
| May 9, 2023 | HYDROmorphone HCl 10 mg in 0.9% Sodium Chloridge, 50 mL syringe (0.2 mg/mL), ... | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... | Class II | SSM Health Care St. Louis DBA SSM St. Clare Hea... |
| May 8, 2023 | Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramusc... | Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the p... | Class III | Amneal Pharmaceuticals of New York, LLC |
| May 3, 2023 | Pin-Away PYRENTAL PAMOATE (Pyrantel base 50 mg / mL) Pinworm Treatment, 2 FL ... | CGMP Deviations: Use of non-food grade lubricant in mixing vessel. | Class II | Denison Pharmaceuticals, LLC |
| May 3, 2023 | Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Do... | CGMP Deviations: Use of non-food grade lubricant in mixing vessel. | Class II | Denison Pharmaceuticals, LLC |
| May 3, 2023 | Buprenorphine Sublingual Tablets, 8 mg, 30 count-bottles, Rx only, Manufactur... | CGMP Deviations | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 3, 2023 | Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottl... | CGMP Deviations: Use of non-food grade lubricant in mixing vessel. | Class II | Denison Pharmaceuticals, LLC |
| May 3, 2023 | Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaife... | CGMP Deviations: Use of non-food grade lubricant in mixing vessel. | Class II | Denison Pharmaceuticals, LLC |
| May 2, 2023 | VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, ... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Ap... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only,... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | Succinylcholine Cl Injection, 100 mg per 5 mL (20 mg/mL), Single-Use Syringe,... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | FentaNYL 50 mcg/mL (2,500mcg Total Dose), 50 mL Syringe, Rx Only, Apollo Care... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe,... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, ... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, A... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Ap... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, ... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, ... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL ... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | Ketamine Injection, 50 mg per 5 mL (10 mg/mL), Single-Use Syringe, Rx only, A... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, A... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 2, 2023 | VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, ... | Lack of Assurance of Sterility | Class II | Apollo Care, LLC |
| May 1, 2023 | Famotidine Tablets, USP, 20mg, 200-count bottle within a carton, Distributed ... | Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an... | Class II | Glenmark Therapeutics, Inc. |
| May 1, 2023 | LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn ... | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... | Class II | RemedyRepack Inc. |
| May 1, 2023 | Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2... | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... | Class II | RemedyRepack Inc. |
| May 1, 2023 | Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, ... | CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product... | Class II | RemedyRepack Inc. |
| Apr 28, 2023 | vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 mL ... | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... | Class II | Central Admixture Pharmacy Services, Inc. |
| Apr 28, 2023 | Neonatal TPN Starter Bag, Amino Acids (Trophamine) 4%/Dextrose 10% with CALCI... | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... | Class II | Central Admixture Pharmacy Services, Inc. |
| Apr 28, 2023 | Cardioplegia Solution, Induction 8:1 High Potassium, 108 mEq K, packaged in 5... | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... | Class II | Central Admixture Pharmacy Services, Inc. |
| Apr 28, 2023 | oxyTOCIN 20 units added to Lactated Ringer's 1,000 mL per bag, Rx only, Centr... | Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the... | Class II | Central Admixture Pharmacy Services, 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.