Browse Drug Recalls
1,198 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,198 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 1,198 FDA drug recalls in 2016.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 9, 2016 | Ondansetron HCI API, Bulk, Manufacturer: Cadila Pharmaceuticals, Ltd., Ankles... | Microbial Contamination of Non-Sterile Product | Class II | Cadila Pharmaceuticals Limited |
| Sep 8, 2016 | GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Singl... | Defective delivery system: detached needles on the syringe in the kit. | Class I | Novo Nordisk Inc |
| Sep 8, 2016 | Lansoprazole Delayed-Release Capsules, USP, 30 mg, packaged in 100-count cart... | Labeling: Label mix-up. The inner packaging was properly labeled Omeprazole DR 40mg Capsules, but... | Class III | Mckesson Packaging Services |
| Sep 7, 2016 | Varithena (polidocanol injectable foam) Administration Pack For Use With Vari... | Defective Delivery System: Incorrect type of syringe found in commercially distributed administra... | Class III | Biocompatibles U.K., Ltd. |
| Sep 2, 2016 | Hyoscyamine Sulfate, USP Tablets, 0.125 mg, 100-count tablets per bottle, Rx ... | Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. | Class I | VIRTUS PHARMACEUTICALS OPCO II L |
| Sep 2, 2016 | EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical... | Non-Sterility: Direct evidence of contamination for 2 lots based on FDA samples. | Class I | United Exchange Corporation |
| Sep 2, 2016 | Hyoscyamine Sulfate, Sublingual Tablets, 0.125 mg, 100-count bottle, Rx only,... | Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. | Class I | VIRTUS PHARMACEUTICALS OPCO II L |
| Sep 2, 2016 | EYE WASH, 4 fl oz. (118 mL) bottle, OTC, Distributed by: Major Pharmaceutical... | Lack of assurance of sterility | Class II | United Exchange Corporation |
| Sep 2, 2016 | Hyoscyamine Sulfate, Orally Disintegrating Tablets, 0.125 mg, 100-count bottl... | Failed Content Uniformity Specifications: resulting in both superpotent and subpotent tablets. | Class I | VIRTUS PHARMACEUTICALS OPCO II L |
| Sep 2, 2016 | Eye Irrigating Solution, 4 fl oz (118 mL) bottle, OTC, Distributed by: Rugby... | Lack of assurance of sterility | Class II | United Exchange Corporation |
| Sep 2, 2016 | Eye Wash, 4 fl oz (118 mL) bottle, OTC, Distributed by: United Exchange Corp... | Lack of assurance of sterility | Class II | United Exchange Corporation |
| Sep 2, 2016 | Vyvanse (lisdexamfetamine dimesylate) Capsules 30 mg, 100 count bottle, Rx On... | Presence of Foreign Tablets/Capsules | Class III | Shire |
| Sep 1, 2016 | Mozobil (plerixafor injection) 24mg/1.2mL (20mg/mL), For Single Use Only, Rx ... | Labeling: Incorrect or Missing Package Insert | Class III | Sanofi-Aventis U.S. LLC |
| Aug 30, 2016 | Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: A... | Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration... | Class III | Actavis Laboratories, FL, Inc. |
| Aug 29, 2016 | ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack... | Failed Dissolution Specifications | Class III | Dr. Reddy's Laboratories, Inc. |
| 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 | Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 6675... | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... | Class II | Sandoz Inc |
| 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 | Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 ... | Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns... | Class II | Sandoz Inc |
| Aug 24, 2016 | Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pac... | Defective Delivery System; reports of damaged product that may alter the predicted release of sco... | Class II | Sandoz Inc |
| 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 23, 2016 | Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: ... | Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out... | Class III | Stason Pharmaceuticals, Inc. |
| Aug 22, 2016 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9... | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... | Class II | Noven Pharmaceuticals, Inc. |
| Aug 22, 2016 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9... | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... | Class II | Noven Pharmaceuticals, Inc. |
| Aug 22, 2016 | Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9... | Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF)... | Class II | Noven Pharmaceuticals, Inc. |
| Aug 19, 2016 | Lamotrigine Tablets, USP, 150 mg, 500-count Tablets per bottle, Rx only, Man... | Tablets/Capsules Imprinted With Wrong ID: incorrect imprint debossed on the tablets. | Class III | Unichem Pharmaceuticals Usa Inc |
| Aug 19, 2016 | Lamotrigine Orally Disintegrating Tablets (ODT), 200 mg, 30 Tablets 3 blister... | Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg bl... | Class I | Impax Laboratories, Inc. |
| Aug 18, 2016 | Amoxicillin For Oral Suspension, USP - Dye Free, 400 mg/5 mL, 100 mL (when re... | Labeling: Label Error on Declared Strength- bottles missing colored coded panel where strength of... | Class III | West-Ward Pharmaceuticals Corp. |
| Aug 16, 2016 | Honeywell eyesaline Eyewash Sterile Isotonic Solution, sterile water 99%, 32 ... | Non Sterility; contaminated with Klebsiella pneumoniae | Class I | Sperian Eye & Face Protection, Inc |
| Aug 15, 2016 | DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be ... | Discoloration: Firm received complaints of product discoloration and particulates. | Class II | Hospira Inc. |
| Aug 10, 2016 | Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) ... | Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product st... | Class II | Allergy Laboratories, Inc. |
| Aug 8, 2016 | Senna Syrup (sennosides) 8.8 mg, 8 fl. oz. (237 mL) bottle, Distributed by: M... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Ninjacof-A (acetaminophen, chlophedianol HCl, pyrilamine maleate) Liquid, 160... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Senexon Liquid (sennosides) 8.8 mg, 8 fl oz. (237 mL) bottle, Distributed by:... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Ninjacof (chlophedianol HCl and pyrilamine maleate) Liquid, 12.5 mg/12.5 mg i... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Aller-Chlor (chlorpheniramine maleate) Syrup, USP, 2 mg in each 5 mL, 4 fl oz... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Sennazon (sennosides) Syrup, 8.8 mg, 8 fl. oz. (237 mL) bottle, Mfd. for: Bay... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 8, 2016 | Diocto Syrup (docusate sodium), 60 mg/15 mL, One Pint (473 mL) bottle, Dist. ... | CGMP Deviations: Recall initiated as a precautionary measure due to a potential risk of product c... | Class II | Pharmatech LLC |
| Aug 5, 2016 | Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 ... | Failed Impurities/Degradation Specifications. | Class III | Teva North America |
| Aug 4, 2016 | Mozobil (plerixafor injection) 24 mg/1.2 mL (20 mg/mL) per vial, Rx Only, For... | Labeling: Incorrect or Missing Lot and/or Exp. Date | Class III | Genzyme Corporation / Genzyme Biosurgery |
| Aug 4, 2016 | Bupivacaine Hydrochloride Inj., USP (2.5 mg/mL) 0.25%, packaged in 30 mL Sing... | Presence of particulate matter: Confirmed customer report for the presence of particulate matter ... | Class I | Hospira Inc., A Pfizer Company |
| 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 |
| Aug 3, 2016 | BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, ... | Failed Dissolution Specifications: Product did not meet dissolution specification at an intermedi... | Class III | Zydus Pharmaceuticals USA 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.