Browse Drug Recalls
15 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 15 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 15 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 25, 2015 | FUROSEMIDE Tablets USP, 40 mg, 1000-count bottle, Rx only, Boehringer Ingelhe... | CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral s... | Class III | Boehringer Ingelheim Roxane Inc |
| Sep 25, 2015 | FUROSEMIDE Tablets USP, 20 mg, 1000-count bottle, Rx only, Boehringer Ingelhe... | CGMP Deviations: The active pharmaceutical ingredient (API) intended for use in furosemide oral s... | Class III | Boehringer Ingelheim Roxane Inc |
| Jul 24, 2015 | COMBIVENT RESPIMAT (ipratropium bromide and albuterol) Inhalation Spray, 20 m... | Defective Delivery System: Inhalers do not spray properly, emitting either no spray or a short tr... | Class II | Boehringer Ingelheim Roxane Inc |
| Apr 2, 2015 | Acarbose Tablets 50 mg a)10 x 10 Unit Dose Tablets per Blister Pack, b)100 co... | Subpotent Drug: The firm received an out of specification result for Assay (potency was below spe... | Class II | Boehringer Ingelheim Roxane Inc |
| Jul 28, 2014 | OXYCODONE HYDROCHLORIDE C II Oral Solution USP, 5 mg/5 mL, 15 mL Vial, Rx onl... | Failed Stability Specifications: Out of specification result for preservative sodium benzoate. | Class III | Boehringer Ingelheim Roxane Inc |
| May 1, 2014 | Calcitriol Oral Solution 1 mcg/mL, 15mL bottle, Rx only, Roxane Laboratories,... | Failed Impurity/Degradation Specification; out of specification for trans-calcitriol degradant at... | Class II | Boehringer Ingelheim Roxane Inc |
| Apr 4, 2014 | Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laborato... | Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the pr... | Class III | Boehringer Ingelheim Roxane Inc |
| Apr 4, 2014 | Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laborator... | Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the pr... | Class III | Boehringer Ingelheim Roxane Inc |
| Mar 27, 2014 | Spiriva HandiHaler (tiotropium bromide inhalation powder), Do Not Swallow Spi... | Defective Delivery System: Potential for dose delivery out of specification due to interation of ... | Class III | Boehringer Ingelheim Roxane Inc |
| Aug 30, 2013 | SPIRIVA HandiHaler (Tiotropium Bromide Inhalation Powder) Capsules 18 mcg per... | Presence of Foreign Substance: This recall is being conducted due to the potential for extrinsic ... | Class III | Boehringer Ingelheim Roxane Inc |
| Jun 14, 2013 | Prednisone Tablet USP, 20 mg tablets, packaged in blisters of ten (10) tablet... | Labeling: Missing Label; missing label on blister card | Class III | Boehringer Ingelheim Roxane Inc |
| Apr 3, 2013 | Oxcarbazepine Oral Suspension, 300 mg/5 mL, 250 mL bottle, Rx only, Boehringe... | Resuspension Problems: Recalled lot did not meet resuspendability requirements. | Class II | Boehringer Ingelheim Roxane Inc |
| Mar 18, 2013 | Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets... | SubPotent Drug: The firm discovered out of specification results for assay and the extended inves... | Class III | Boehringer Ingelheim Roxane Inc |
| Dec 12, 2012 | Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringe... | Impurities/Degradation Products: Out of Specification results found for impurity B, identified as... | Class III | Boehringer Ingelheim Roxane Inc |
| Nov 5, 2012 | Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Di... | Defective container; damaged bottles could allow moisture to get into the bottle and thus may imp... | Class II | Boehringer Ingelheim Roxane 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.