Browse Drug Recalls
607 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 607 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 607 FDA drug recalls in OH.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 19, 2019 | FENTANYL 2MCG/ML BUPIVACAINE 0.125% IN NACL 0.9% SRY C-II, 50ML per syringe (... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | PYRIDOXINE (PFV) 100MG/ML, 30ML PER VIAL. RXQ Compounding, 340 West State Str... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | ONDANSETRON 2 MG/ML INJECTION SOLUTION (PFV), 2 ML per vial, RXQ Compounding,... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | HYDROMORPHONE 0.2MG/ML IN NACL 0.9% SYR (C-II) , [a) 50 ML NDC 70731-0114-89;... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | BUFFERED LIDOCAINE HCL 1% INJECTION SOL (PF) SYR, 0.5 ML per vial, RXQ Compou... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | TRAVASOL 10% (AMINO ACID) INJECTION SOLUTION, 50 ML per Vial, RXQ Compounding... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | MORPHINE 1MG/ML IN NACL 0.9% 55ML SYR (C-II), 55 ML per vial, RXQ Compounding... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | VITAMIN B COMPLEX 100 (MDV), 30 ML per Vial, RXQ Compounding, 340 West State ... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | GLUTATHIONE 200MG/ML (MDV) INJECTION SOLN, 30 ML per vial, RXQ Compounding, 3... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| May 13, 2019 | Pramipexole Dihydrochloride Tablets, 0.25 mg, 100 Tablets (10 x 10), Rx Only,... | GMP Deviations; possible cross contamination of product due to cleaning procedure failure. | Class II | American Health Packaging |
| May 13, 2019 | Pramipexole Dihydrochloride Tablets, 0.5 mg, 30 Tablets (6 tablets per bliste... | GMP Deviations; possible cross contamination of product due to cleaning procedure failure. | Class II | American Health Packaging |
| May 13, 2019 | Pramipexole Dihydrochloride Tablets, 1.0 mg, 30 Tablets (6 tablets per bliste... | GMP Deviations; possible cross contamination of product due to cleaning procedure failure. | Class II | American Health Packaging |
| May 13, 2019 | Pramipexole Dihydrochloride Tablets, 0.125 mg, 30 Tablets (6 tablets per blis... | GMP Deviations; possible cross contamination of product due to cleaning procedure failure. | Class II | American Health Packaging |
| May 9, 2019 | Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Onl... | GMP Deviations: Potential cross contamination due to cleaning procedure failure. | Class II | American Health Packaging |
| May 9, 2019 | Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count... | GMP Deviations: Potential cross contamination due to cleaning procedure failure. | Class II | American Health Packaging |
| Apr 8, 2019 | GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Pac... | Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug r... | Class II | American Health Packaging |
| Mar 6, 2019 | Valsartan Tablets USP 160 mg, 100 Tablets (10 x 10) per Unit Dose Blisters, ... | CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the... | Class II | American Health Packaging |
| Mar 1, 2019 | Aspirin and Extended-release Dipyridamole Capsules, 25 mg/200 mg, 20 capsules... | Failed Impurities/Degradation Specifications; out of specification result for an unknown impurity... | Class II | American Health Packaging |
| Feb 19, 2019 | Lovastatin Tablets USP, 40 mg, packaged in a) 100-count bottles (NDC 68001-31... | CGMP Deviations: Finished product made with lovastatin drug substance that was out of specificati... | Class III | American Health Packaging |
| Nov 9, 2018 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100-count Un... | Cross contamination with other products: This sub-recall is being initiated in support of the rec... | Class III | AMERICAN HEALTH PACKAGING |
| Sep 25, 2018 | Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx ... | Subpotent drug: During testing of the retention sample, the firm discovered that the product was ... | Class II | RXQ Compounding LLC |
| Aug 1, 2018 | Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10 Unit ... | Failed Dissolution Specifications: Out of specification result for the dissolution test. | Class II | American Health Packaging |
| Jul 24, 2018 | Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufact... | Failed Dissolution Specifications: | Class II | West-Ward Columbus Inc |
| Jul 24, 2018 | Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufac... | Failed Dissolution Specifications: | Class II | West-Ward Columbus Inc |
| Jun 25, 2018 | Enalapril Maleate Tablets USP, 5 mg, 100 Tablets (10X10) blister cards, 12 ca... | Failed Impurities/Degradation Specification; out-of-specification results for the Enalapril DKT d... | Class III | AMERICAN HEALTH PACKAGING |
| Mar 19, 2018 | Tramadol Hydrochloride 50 mg tablets, 120-count, Rx Only; Distributed by Qual... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Lake Erie Medical & Surgical Supply Inc |
| Jan 19, 2018 | Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [N... | CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intende... | Class II | AMERICAN HEALTH PACKAGING |
| Oct 24, 2017 | Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed b... | Presence of Foreign Tablets/Capsules. | Class II | Amerisource Health Services |
| 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 |
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.