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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.