Browse Drug Recalls
629 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 629 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 629 FDA drug recalls in OH.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 31, 2014 | CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per vial, Rx o... | Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container clo... | Class II | Ben Venue Laboratories 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 |
| 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 |
| Jul 1, 2014 | Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Pa... | Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... | Class I | American Health Packaging |
| 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 |
| Feb 14, 2014 | Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratorie... | Presence of Particulate Matter: During a review of retain samples, the firm found a glass particu... | Class I | Ben Venue Laboratories Inc |
| Jan 31, 2014 | HydrOXYzine HCl Tablets, USP 50 mg, 100 Tablet Blister, Rx only Mfd by: KVK-... | Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from... | Class II | American Health Packaging |
| Jan 31, 2014 | HydrOXYzine HCl Tablets, USP 25 mg, 100 Tablet Blister, Rx only Mfd by: KVK-... | Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from... | Class II | American Health Packaging |
| Oct 2, 2013 | Potassium Chloride, microencapsulated extended-release tablets, 20 mEq, blist... | Labeling: Incorrect or Missing Package Insert: the package insert for the potassium chloride 8 mE... | Class III | Cardinal Health |
| 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 |
| Aug 29, 2013 | Vicks NyQuil Cold and Flu Nighttime Relief, Liquid Twin Pack, (Acetaminophen ... | Incorrect/ Undeclared Excipients: NyQuil Liquid Original bottles were inadvertently overwrapped w... | Class II | Procter & Gamble Co |
| Aug 2, 2013 | Valacyclovir HCl Tablets, 500 mg, 100 tablets (10x10) blister cards, Rx only,... | Subpotent | Class II | American Health Packaging |
| Jul 3, 2013 | DayQuil Sinex DayTime Sinus Relief (acetaminophen 325 mg and phenylephrine HC... | Unit Dose Mispackaging: Product packaging defect which could result in code date smearing, incomp... | Class II | Procter & Gamble Co |
| Jun 21, 2013 | I MUSTACHE YOU TO BE MY BFF Justice, COTTON CANDY scent anti bac, Ethyl Alcoh... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | I love sleep overs Justice, Grape anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, D... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | BFF's are COOL! Justice, CHERRY SCENT ANTI BAC, Ethyl Alcohol, Net Wt. 1 fl o... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | GIRLS ROCK Justice, VANILLA scent anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, D... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Share a Smile Mixed berry Anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | I love my BFF Justice, Watermelon anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, D... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | YOU CANT HANDLE THIS Justice, GRAPE SCENT ANTI BAC, Ethyl Alcohol Net Wt. 1 f... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | I love to shop Justice, Peach anti bac, Ethyl Alcohol, Net Wt. 1 fl oz, Distr... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Shine from within blueberry Anti bac Justice, Ethyl Alcohol, Net Wt 1 fl oz, ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Girls can change the World, Green Apple Anti bac Justice, Ethyl Alcohol, Net ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | Lemon anti bac Justice, Ethyl Alcohol, Net Wt. 1 fl oz, Distr by Tween Brands... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | LIFE IS SWEET! Justice, Vanilla Scent anti bac, Ethyl Alcohol, Net Wt. 1 fl ... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands Inc |
| Jun 21, 2013 | TODAY IS AWESOME! Justice, Cotton Candy anti bac, Ethyl Alcohol, Net Wt. 1 fl... | Labeling: Label Error on Declared Strength; the label states that the product contains 62% ethyl ... | Class III | Tween Brands 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.