Browse Drug Recalls
68 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 68 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 68 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Aug 4, 2016 | buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count ... | Failed dissolution specifications - the out of specification result for dissolution was identifie... | Class III | 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 |
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.