Browse Drug Recalls
119 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 119 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 119 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 7, 2023 | Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 1... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufacture... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Table... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for:... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured f... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets ND... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bot... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufact... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets ND... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Feb 7, 2023 | Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured ... | CGMP Deviations: recalling drug products following an FDA inspection. | Class II | Accord Healthcare, Inc. |
| Jan 12, 2023 | Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for:... | Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack t... | Class II | Accord Healthcare, Inc. |
| Nov 29, 2022 | Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufacture... | Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomyc... | Class I | Accord Healthcare, Inc. |
| Jan 28, 2021 | Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose V... | Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled fo... | Class III | Accord Healthcare, Inc. |
| Jul 27, 2020 | Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Cal... | CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... | Class II | Calvin Scott & Company, Inc. |
| Aug 21, 2018 | Hydrochlorothiazide Tablets USP, 12.5 mg, 100-count bottle, Rx Only, Manufact... | Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets US... | Class I | Accord Healthcare, Inc. |
| Dec 20, 2016 | Lisinopril tablets, 5 mg, 1000-count bottle, Rx only, Manufactured for Accord... | Failed tablet/capsule specification: missing break line on the 5mg tablet. | Class II | Accord Healthcare, 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.