Browse Drug Recalls

112 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 112 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 112 FDA drug recalls.

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DateProductReasonClassFirm
May 9, 2019 Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Onl... GMP Deviations: Potential cross contamination due to cleaning procedure failure. Class II American Health Packaging
May 9, 2019 Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count... GMP Deviations: Potential cross contamination due to cleaning procedure failure. Class II American Health Packaging
Apr 8, 2019 GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Pac... Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug r... Class II American Health Packaging
Mar 6, 2019 Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, ... CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... Class II American Health Packaging
Mar 1, 2019 Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules... Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity... Class II American Health Packaging
Feb 19, 2019 Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-31... CGMP Deviations: Finished product made with lovastatin drug substance that was out of specificati... Class III American Health Packaging
Nov 9, 2018 Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Un... Cross contamination with other products: This sub-recall is being initiated in support of the rec... Class III AMERICAN HEALTH PACKAGING
Aug 1, 2018 Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit ... Failed Dissolution Specifications: Out of specification result for the dissolution test. Class II American Health Packaging
Jun 25, 2018 Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 ca... Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT d... Class III AMERICAN HEALTH PACKAGING
Jan 19, 2018 Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [N... CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intende... Class II AMERICAN HEALTH PACKAGING
Oct 24, 2017 Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed b... Presence of Foreign Tablets/Capsules. Class II Amerisource Health Services
Aug 29, 2017 Enalapril Maleate Tablets, USP, 5 mg, 100 Tablets (10 x 10), Rx Only. Packag... Failed Stability Specifications Class III Amerisource Health Services
Feb 8, 2017 CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, ... Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown I... Class II Amerisource Health Services
Feb 3, 2017 GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21... Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specificati... Class II Amerisource Health Services
Oct 13, 2016 AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Indi... Presence of Foreign Tablets/Capsules Class III Amerisource Health Services
Sep 30, 2016 Paricalcitol Capsules, 1 mcg, packaged in 30 Capsules (5 x 6) per carton (NDC... Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufac... Class III Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Aug 24, 2016 Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... Unit Dose Mispackaging; blister cavities may contain more than one tablet /capsule Class II Amerisource Health Services
Mar 31, 2016 Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs ... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Amerisource Health Services
Mar 31, 2016 Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Bliste... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Amerisource Health Services
Jan 26, 2016 Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Di... Failed Impurities/Degradation Specifications; 9 month stability (manufacturer) Class III Amerisource Health Services
Jan 18, 2016 Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister car... Failed Dissolution Specifications: Unexplained low out of specification results for dissolution. Class II Amerisource Health Services
Oct 29, 2015 HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton,... Presence of Particulate Matter Class II Amerisource Health Services
Jun 26, 2015 Desmopressin Acetate Tablets, 0.1 mg Tablets, Rx Only, Packed in 30 Tablet (3... Tablets/Capsules Imprinted with Wrong ID: Some tablets incorrectly imprinted with an X on one side. Class III American Health Packaging
Jun 1, 2015 Azithromycin tablets, USP 600mg, packaged in 10-count blisters (NDC 68084-464... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 10mg packaged in 10-count blisters (NDC 68084-061-11)... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 6808... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11)... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11)... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11);... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Zonisamide capsules, USP 100mg packaged in 10-count blisters (NDC 68084-008-1... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Amlodipine besylate tablets, USP 2.5mg, packaged in 10-count blisters (NDC 68... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Jun 1, 2015 Clarithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-4... CGMP Deviations: Firm did not adequately investigate customer complaints. Class II American Health Packaging
Mar 2, 2015 Lamivudine and Zidovudine Tablets USP 150mg/300mg 30 Unit Dose Blisters, Rx O... Failed dissolution specifications Class II American Health Packaging
Jan 6, 2015 Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and D... Failed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet caps... Class II American Health Packaging
Nov 19, 2014 Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters pe... Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratori... Class II American Health Packaging
Oct 10, 2014 MethylPREDNISolone Tablets, USP, 4 mg, 100 unit dose blisters, Packaged and D... Subpotent; 6 month stability time point Class III American Health Packaging
Jul 1, 2014 Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Pac... Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... Class I American Health Packaging

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.