Browse Drug Recalls

105 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 105 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 105 FDA drug recalls.

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DateProductReasonClassFirm
Feb 7, 2022 Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: ... Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubrican... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Oct 22, 2021 Pregabalin Capsules, 50 mg, 100 count bottle, Rx only, Distributed by: Sun Ph... Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution... Class II SUN PHARMACEUTICAL INDUSTRIES INC
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 4, 2021 Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bo... Presence of foreign substance: identified as activated carbon. Class II SUN PHARMACEUTICAL INDUSTRIES INC
Mar 25, 2021 Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottl... Failed Moisture Limits: Out of specification for water content Class III SUN PHARMACEUTICAL INDUSTRIES INC
Mar 15, 2021 CLINDAMYCIN HYDROCHLORIDE CAPSULES, USP,150MG 100-count bottles, Rx Only, Man... CGMP Deviations: Intermittent exposure to temperature excursion during storage. Class II Cardinal Health Inc.
Feb 5, 2021 Pantoprazole Sodium for Injection 40mg/vial For I.V. infusion only Distribute... Failed Impurity/Degradation Specifications Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jul 6, 2020 Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx ... Cross contamination with other products - OOS discovered during routine stability testing for hig... Class III SUN PHARMACEUTICAL INDUSTRIES INC
Mar 13, 2020 Doxycycline Capsules, USP, 100 mg, 50-count bottle, Rx only, Manufactured by:... CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Prac... Class II Sun Pharmaceutical Industries, Inc.
Mar 13, 2020 Doxycycline Capsules, USP, 75 mg, 100-count bottle, Rx only, Manufactured by:... CGMP Deviations: Doxycycline capsules were not manufactured under Current Good Manufacturing Prac... Class II Sun Pharmaceutical Industries, Inc.
Mar 9, 2020 Atorvastatin Calcium Tablets, USP 40 mg, Rx only, 500-count bottle, Manufactu... Presence of foreign substance: Foreign matter has been identified as latex glove in one lot of At... Class II Sun Pharmaceutical Industries, Inc.
Jan 14, 2020 Testosterone Cypionate for Injection, 2,000 mg/10 mL (200 mg/mL), a) 1 mL Sin... cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a prev... Class II Sun Pharmaceutical Industries, Inc.
Jan 14, 2020 Testosterone Cypionate for Injection, USP, 1,000 mg/10 mL (100 mg/mL), 10 mL ... cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a prev... Class II Sun Pharmaceutical Industries, Inc.
Dec 26, 2019 Sumatriptan Succinate Tablets, 50 mg, packaged in a) 9 (1x9) Unit-of use blis... Failed Impurities/Degradation Specifications; out-of-specification results obtained for related s... Class II Sun Pharmaceutical Industries, Inc.
Dec 26, 2019 Sumatriptan Succinate Tablets, 100 mg packaged in 9 (1X9) Unit-of-use bliste... Failed Impurities/Degradation Specifications; out-of-specification results obtained for related s... Class II Sun Pharmaceutical Industries, Inc.
Jun 5, 2019 Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg/ Extended-Relea... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jun 5, 2019 Wal-Fex D Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extended-Releas... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jun 5, 2019 Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Extende... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jun 5, 2019 Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg, Exten... Testing of Fexofenadine HCl and Pseudoephedrine Failed Impurities/Degradation Specifications: ele... Class II Sun Pharmaceutical Industries, Inc.
Jan 24, 2019 BromSite (bromfenac ophthalmic solution) 0.075%, 5 mL bottles, Rx Only, Distr... Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance. Class II Sun Pharmaceutical Industries, Inc.
Jan 3, 2019 Vecuronium Bromide for Injection 20 mg* *1mg/mL when reconstituted to 20 mL L... Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromid... Class I Sun Pharmaceutical Industries, Inc.
Jan 3, 2019 Vecuronium Bromide for Injection 10 mg*, *1mg/mL when reconstituted to 10 mL ... Presence of Particulate Matter: Foreign matter identified as glass detected in Vecuronium Bromid... Class I Sun Pharmaceutical Industries, Inc.
Dec 26, 2018 LOPERAMIDE HCL TABLETS USP, 2 mg, ANTI-DIARRHEAL, 24 caplets per carton, OTC... Labeling Not Elsewhere Classified: The front panel indicates 24 caplets whereas the side panel i... Class III Sun Pharmaceutical Industries, Inc.
Dec 7, 2018 Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Pa... Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained dur... Class III Sun Pharmaceutical Industries, Inc.
Jul 12, 2018 Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distr... Presence of Particulate Matter: organic and inorganic compounds detected in vials of product. Class II Sun Pharmaceutical Industries, Inc.
Jul 3, 2018 Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a ... Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, ... Class II Sun Pharmaceutical Industries, Inc.
Apr 26, 2018 Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473... Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to... Class III Sun Pharmaceutical Industries, Inc.
Apr 19, 2018 Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-co... Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimeth... Class II Sun Pharmaceutical Industries, Inc.
Feb 5, 2018 Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, ... Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a fa... Class III Sun Pharmaceutical Industries, Inc.
Jan 16, 2018 DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Si... Lack Of Assurance Of Sterility Class II Sun Pharmaceutical Industries, Inc.
Apr 18, 2017 Children's Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30-count bottle, ... Failed Tablet/Capsule Specifications: out of specification results for increased tablet hardness. Class III Sun Pharmaceutical Industries, Inc.
Apr 18, 2017 Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, ... Microbial Contamination of Non-Sterile Products Class II Sun Pharmaceutical Industries, Inc.
Mar 22, 2017 Olanzapine Tablets, 20 mg, packaged in a) 30-count bottles (NDC 62756-556-83)... Failed Impurities/Degradation Specifications: out of specification results for the related substa... Class III Sun Pharmaceutical Industries, Inc.
Mar 22, 2017 Olanzapine Tablets, 10 mg, packaged in a) 30-count bottles (NDC 62756-554-83)... Failed Impurities/Degradation Specifications: out of specification results for the related substa... Class III Sun Pharmaceutical Industries, Inc.
Mar 22, 2017 Olanzapine Tablets, 2.5 mg, 1000-count bottles, Rx Only, Distributed by: Sun ... Failed Impurities/Degradation Specifications: out of specification results for the related substa... Class III Sun Pharmaceutical Industries, Inc.
Mar 22, 2017 Olanzapine Tablets, 7.5 mg, packaged in a) 30-count bottles (NDC 62756-553-83... Failed Impurities/Degradation Specifications: out of specification results for the related substa... Class III Sun Pharmaceutical Industries, Inc.
Mar 15, 2017 Testosterone Cypionate Injection , USP, 200 mg/mL, 1 mL vial , For Intramusc... Presence of Particulate Matter Class II Sun Pharmaceutical Industries, Inc.
Jan 12, 2017 Sun Pharma Carbidopa and Levodopa Tablets USP 25 mg/250 mg a) 100-count bottl... Failed Dissolution Specifications Class II Sun Pharmaceutical Industries, Inc.
Jan 5, 2017 Alfuzosin Hydrochloride Extended-release Tablets, 10 mg, 100-count bottles, R... Presence of Foreign Substance: consumer complaint for foreign matter embedded in the tablet ident... Class II Sun Pharmaceutical Industries, Inc.
Dec 20, 2016 buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count ... Failed Dissolution Specifications; 18 month stability time point Class III Sun Pharmaceutical Industries, Inc.
Dec 20, 2016 buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (ND... Failed Dissolution Specifications; 18 month stability time point Class III Sun Pharmaceutical Industries, Inc.
Oct 28, 2016 KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP,... Failed Stability Specifications: Low Out of Specification results for alcohol content. Class III Sun Pharmaceutical Industries, Inc.
Sep 13, 2016 buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-D... Failed Dissolution Specifications Class III Sun Pharmaceutical Industries, Inc.
Jun 27, 2016 Carvediol Tablets, USP, 25 mg, 100-count bottle (NDC 57664-247-88), 500-count... Failed Impurities/Degradation Specifications Class III Sun Pharmaceutical Industries, Inc.
Jun 27, 2016 Carvediol Tablets, USP, 12.5 mg, 500-count bottle (NDC 57664-245-13), 1000-c... Failed Impurities/Degradation Specifications Class III Sun Pharmaceutical Industries, Inc.
Jun 27, 2016 buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 t... Failed Dissolution Specifications Class III Sun Pharmaceutical Industries, Inc.
Jun 27, 2016 Carvediol Tablets, USP, 6.25 mg, 100-count bottle (NDC 57664-244-18), 500-cou... Failed Impurities/Degradation Specifications Class III Sun Pharmaceutical Industries, Inc.
Jun 27, 2016 Carvediol Tablets , USP, 3.125 mg, 100-count bottle (NDC 57664-242-88). 500-c... Failed Impurities/Degradation Specifications Class III Sun Pharmaceutical Industries, Inc.
May 23, 2016 Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY T... Failed Dissolution Specifications Class II Nostrum Laboratories, Inc.
Feb 11, 2016 Alendronate Sodium Tablets, USP, 70 mg*, 4-count blisters per carton, Rx only... Failed Impurities/Degradation Specifications: Observed levels of highest unknown impurity exceedi... Class II Sun Pharma Global Fze

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.