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 |
|---|---|---|---|---|
| Jun 19, 2019 | TURBO CAINE 2.5 (PHEN2.5/CYCLO1/ TROP1/TETRA 0.5), 0.4 ML per Syringe, RXQ Co... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | KETAMINE 10 MG/ML INJ SOL SYR (C-III), [a) 2 ML NDC: 70731-0132-02; b) 5 ML N... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | HYDROXOCOBALAMIN 1000 MCG/ML (MDV), 30 ML per vial, RXQ Compounding, 340 West... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | TURBO DROPS (PHEN 10% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per dr... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | LIDOCAINE HCL 2% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 34... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | MANGANESE SULFATE MONOHYDRATE (PFV) 0.1MG/ML INJ, 10 ML per syringe, RXQ Comp... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | PYRIDOXINE (MDV) 100MG/ML, 30ML PER VIAL, RXQ Compounding, 340 West State Str... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | SOD-PHOS (PHOS 3MMOL/ML-SOD 4MEQ/ML) PFV INJ SOLN, 10 ML PER VIAL, RXQ Compo... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | PHO-TID-CHOL 50MG/ DEOXYCHOLIC 42 MG/ML INJ, 30 ML per vial, RXQ Compounding,... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | CALCIUM GLUCONATE 5% INJECTION SOLUTION (MDV), 20 ML per vial, RXQ Compoundin... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | ZINC SULFATE 1MG/ML INJECTION SOLUTION, 30ML per VIAL, RXQ Compounding, 340 W... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | SUCCINYLCHOLINE CHLORIDE 20MG/ML INJ SOL, 10 ML per Vial, RXQ Compounding, 34... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | EDETATE DISODIUM 30% INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West S... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | MAGNESIUM CHLORIDE HEXAHYDRATE (MDV) 20% INJ SOLN, 50 ML per vial, RXQ Compou... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | METHYLCOBALAMIN 10MG/ML INJECTABLE SOLUTION (MDV), 10 ML per vial, RXQ Compou... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | EDETATE DISODIUM 15% INJECTABLE, 100 ML per vial, RXQ Compounding, 340 West S... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | MIC B12 W/B6 (LIPOSTAT PLUS) 25/50/50/1/.175 MG/ML, 30 ML per vial, RXQ Compo... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | TURBO DROPS (PHEN 2.5% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per d... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | RIBOFLAVIN 0.1% OPHTHALMIC SOLUTION SYRINGE, 2 ML per syringe. RXQ Compoundin... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | SODIUM BICARBONATE 8.4% (1 MEQ/ML) INJ SOLN (PFV), 50 ML PER VIAL, RXQ Compou... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | MAGNESIUM CHLORIDE HEXAHYDRATE (PFV) 20% INJ SOLN, 50 ML per vial, RXQ Compou... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | PROCAINE HCL (PFV) 20 MG/ML INJECTABLE SOLUTION, 30 ML per vial, RXQ Compound... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| 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 |
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.