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, 2017 | methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Co... | Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves u... | Class II | RXQ Compounding LLC |
| 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 |
| Apr 4, 2017 | Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by ... | Failed Tablet/Capsule Specifications; during an internal inspection, capsules were found with ill... | Class III | West-Ward Columbus, Inc. |
| 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 |
| Dec 22, 2016 | Furosemide Tablets USP, 20 mg, 1000 count bottles, Rx only, Roxane Laboratori... | Failed Tablet/Capsule Specifications: An unusually thick tablet was reported through a complaint. | Class II | Roxane Laboratories, Inc. |
| Dec 14, 2016 | Azelastine Hydrochloride Nasal Solution (Nasal Spray), 0.1% (137 mcg per spra... | Defective Delivery System: out of specification result for droplet size distribution at the d90 m... | Class III | Roxane Laboratories, Inc. |
| Oct 27, 2016 | Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-co... | Failed Dissolution Specifications: The firm was notified that there was a dissolution out of spec... | Class III | 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 |
| Oct 3, 2016 | PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-War... | Failed Tablet/Capsule Specifications: Discovery of an underweight tablet. | Class II | West-Ward Pharmaceutical |
| 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 |
| May 23, 2016 | Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY T... | Failed Dissolution Specifications | Class II | Nostrum Laboratories, Inc. |
| May 19, 2016 | Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehring... | Failed Impurities/Degradation Specification; 9 month stability | Class III | West-Ward Columbus Inc |
| May 11, 2016 | tabcin NOCHE; Capsules,12-count box, UPC 501008485033 | CGMP Deviations | Class II | Profarma Distributors LLC |
| May 11, 2016 | VERMOX Tablets 100 mg; 6-count box, UPC 7501109900619 | CGMP Deviations | Class II | Profarma Distributors LLC |
| May 11, 2016 | tabcin ACTIVE M.R. Capsules, 12-count box , UPC 7501008485057 | CGMP Deviations | Class II | Profarma Distributors LLC |
| May 11, 2016 | VERMOX Tablets 500 mg, 1-count box, UPC 501109900596 | CGMP Deviations | Class II | Profarma Distributors LLC |
| May 11, 2016 | 1% Clotrimazol cream, 30 mg tube, UPC 501318644335 | CGMP Deviations | Class II | Profarma Distributors LLC |
| 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 |
| Dec 15, 2015 | ZI XIU TANG BEAUTY FACE & FIGURE Capsules, 250 mg, 60-count bottles | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Asset extreme+PLUS Capsules, 500 mg, 30-count bottles, Distributed by Descor... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | XCEL Capsules, 300 mg, 60-count bottles, Manufactured for JNS Health | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | EVOLVE BEE POLLEN Capsules, 250mg, 60-count bottles, Manufactured for 2637 E.... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | XCEL ADVANCED Capsules, 350mg, 60-count bottles, Manufactured for JNS Health | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Prime Capsules, 500mg, 60-count bottles, Distributed By Zagonfly 3129 25th St... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Jenesis Capsules, 350 mg, 60-count bottles, Manufactured for Timeless Soluti... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Infinity Capsules, 500 mg, 30-count bottle, Manufactured for Floyd Nutrition | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | La' Trim Plus Capsules, 350 mg, 60-count bottles, Manufactured for: MWN Heal... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | SLIM TRIM U Capsules, 250mg, 60-count bottles, Manufactured for Floyd Nutrition | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Ultimate Formula Capsules, 250mg, 48-count bottles, Manufactured for: Zi Xiu ... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Oasis Capsules, 500mg, 45-count bottles, Manufactured for: MWN Health 37 N O... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | Asset BOLD Capsules, 500 mg, 60-count bottles, Distributed by Descor, LLC www... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Dec 15, 2015 | SlimeX-15 Capsules, 15 mg, 30-count bottles, Marketed by: Signature Pharmaceu... | Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product ... | Class I | Bee Extremely Amazed LLC |
| Nov 29, 2015 | Oxygen, USP, 99.0%, Bulk Cryogenic Liquid, Rx, Airgas Merchant Gases, LLC, In... | cGMP Deviations; trailer may not have met GMP requirements prior to filling | Class II | AGA Gas Inc |
| Oct 29, 2015 | HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton,... | Presence of Particulate Matter | Class II | Amerisource Health Services |
| 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 |
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.