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Browse Drug Recalls

182 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 182 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 182 FDA drug recalls.

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DateProductReasonClassFirm
Jan 4, 2022 Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedr... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Rele... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Na... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudo... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrin... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephe... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Jan 4, 2022 QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Exten... Failed Dissolution Specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets U... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoe... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablet... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Exte... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine H... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Oct 14, 2021 Ezetimibe and Simvastatin Tablets, 10 mg/80mg, 500 tablet bottles, Rx only, M... Failed Excipient Specification; product manufactured using an excipient found to be OOS for condu... Class II Golden State Medical Supply Inc.
Oct 14, 2021 Ezetimibe and Simvastatin Tablets, 10 mg/40mg, a) 90 Tablets, b) 500 tablets,... Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured us... Class II Golden State Medical Supply Inc.
Oct 5, 2021 Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC ... Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... Class II Dr. Reddy's Laboratories, Inc.
Oct 5, 2021 Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottle... Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured us... Class II Dr. Reddy's Laboratories, Inc.
Oct 5, 2021 Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC ... Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... Class II Dr. Reddy's Laboratories, Inc.
Oct 5, 2021 Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC ... Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... Class II Dr. Reddy's Laboratories, Inc.
Oct 5, 2021 Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC ... Failed Excipient Specifications; product manufactured using an excipient found to be OOS for cond... Class II Dr. Reddy's Laboratories, Inc.
Oct 5, 2021 Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole... CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within ... Class II Dr. Reddy's Laboratories, Inc.
Jul 19, 2021 Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Red... Failed Tablet/Capsule Specification: Some tablets are shaved Class II Dr. Reddy's Laboratories, Inc.
Jun 4, 2021 Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Redd... Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities Class III Dr. Reddy's Laboratories, Inc.
May 4, 2021 Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: ... Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities Class III Dr. Reddy's Laboratories, Inc.
Feb 26, 2021 Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Di... Failed Dissolution Specifications: Out-of-specification results observed for dissolution during s... Class II Dr. Reddy's Laboratories, Inc.
Feb 19, 2021 Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 5511... Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and... Class III Dr. Reddy's Laboratories, Inc.
Feb 17, 2021 Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-3... Failed Dissolution Specifications Class II Dr. Reddy's Laboratories, Inc.
Apr 24, 2020 Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bott... Discoloration: product contains brown pellets Class III Dr. Reddy's Laboratories, Inc.
Mar 16, 2020 Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11... Defective Container: Recall is due to breaking and shattering of ampules upon opening Class I 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 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 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 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 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 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 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 Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OT... 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 30142-505-34), b.) ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC 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 0363-0131-30), b.) ... 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 63868-480-24), b.) ... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC. CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger) CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC. CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, Inc.
Oct 1, 2019 Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count b... 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.) 65 count bottles (NDC 49035-404-61) b.) 1... CGMP Deviations: Presence of NDMA impurity detected in product. Class II Dr. Reddy's Laboratories, 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.