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 |
|---|---|---|---|---|
| Mar 15, 2021 | LEUCOVORIN 15MG 24; NDC/UPC 54449810; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | PREGABALIN CAPSULES 300MG 90 ; NDC 43598-298-90; RX; CAPSULES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 5... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Medroxyprogesterone acetate injectable suspension, USP 150 mg per mL 1 mL Pre... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Intrarosa Prasterone Vaginal Inserts 6.5 mg 28 inserts/applicators Rx Only Ma... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | medroxyprogesterone acetate injectable suspension, USP, 150MG/ML 1ML, Rx Onl... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Triumeq (abacavir, dolutegravir, and lamivudine) 600 mg/50 mg/300 mg Tablets ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | PROMETHAZINE PLAIN ORAL SOLUTION 6.25MG/5ML 473ML; ; RX; SOLUTION (USUALLY NO... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Triamcinolone Acetonide Ointment, USP, 0.025% 80g; Rx Only, Distributed by: P... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | MICONAZOLE 7 2% 45GM APL; NDC/UPC 009047734459; OTC; CREAM | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt.... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topi... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Ivermectin Tablets USP 3 mg 20 Tablets (2 Foil Strips of 10 tablets each) Rx ... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Iron 100 with Vitamin C Tablets Dietary Supplement 100 Tablets NDC 60258-099-... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | EZETIMIBE AND SIMVASTATIN TABLETS 10-10MG 30; NDC/UPC 68462-321-30; RX; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAP... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Infants Aqueous Vitamin D Oral Drops 400 IU/mL 50 mL (1 2/3 fl oz) Manufactru... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containi... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 15, 2021 | Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 9, 2021 | Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe ... | Temperature Abuse | Class III | Cardinal Health Inc. |
| Jan 7, 2021 | Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per cart... | Failed Dissolution Specifications | Class II | American Health Packaging |
| Oct 21, 2020 | Union (black) salve packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; d) 8 oz.; e) 1... | CGMP Deviations | Class II | H & H Remedies, LLC |
| Oct 21, 2020 | White Liniment packaged in a) 1 oz; b) 4 oz.; and c) 6 oz bottles. Mfg & Sold... | CGMP Deviations | Class II | H & H Remedies, LLC |
| Oct 21, 2020 | Vapor Ointment packaged in a) 1/8 oz; b) 2 oz.; c) 4 oz.; and d) 8 oz jars. M... | CGMP Deviations | Class II | H & H Remedies, LLC |
| Jul 22, 2020 | Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr.... | Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code. | Class III | West-Ward Columbus Inc |
| Jul 1, 2020 | Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), F... | Microbial contamination of non-sterile products: positive microbial contamination in product. | Class I | Spartan Chemical Co Inc |
| Jun 10, 2020 | Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blis... | Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medi... | Class III | American Health Packaging |
| May 19, 2020 | Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx ... | Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month tim... | Class II | American Health Packaging |
| May 13, 2020 | Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. b... | Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degra... | Class III | West-Ward Columbus Inc |
| May 13, 2020 | Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC ... | Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf l... | Class II | West-Ward Columbus Inc |
| Feb 7, 2020 | Desmopressin Acetate Tablets, 0.2 mg, 30 tablets (3 x 10 unit dose blister ca... | GMP Deviations: Product bottle may be absent of desiccant. | Class II | American Health Packaging |
| Feb 7, 2020 | Desmopressin Acetate Tablets, 0.1 mg, 30 tablets (3 x 10 unit dose blister ca... | GMP Deviations: Product bottle may be absent of desiccant. | Class II | American Health Packaging |
| Dec 4, 2019 | Raloxifene Hydrochloride Tablets, USP, 60 mg, 30 Tablets (3 x 10 blister card... | Failed Dissolution Specifications: Low out of specification results obtained during stability tes... | Class II | American Health Packaging |
| Nov 20, 2019 | Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), ... | CGMP Deviations: Potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the ... | Class II | American Health Packaging |
| Nov 1, 2019 | Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per c... | CGMP Deviations: Presence of NDMA impurity detected in product. | Class II | American Health Packaging |
| Sep 9, 2019 | Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, ... | Failed Impurities/Degradation Specificattion | Class II | West-Ward Columbus Inc |
| Aug 27, 2019 | Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, N... | Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths secti... | Class III | American Health Packaging |
| Aug 9, 2019 | Carbamazepine, Extended-Release Tablets, USP, 400 mg, 30 Tablets (3 blister c... | Failed Dissolution Specifications | Class II | American Health Packaging |
| Aug 8, 2019 | Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial.... | Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed... | Class II | Alkermes Inc |
| Jun 19, 2019 | EDETATE CALCIUM DISODIUM 150MG/ML INJECTABLE, 100 ML per vial, RXQ Compoundin... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | NEOSTIGMINE METHYL SULFATE 1MG/ML INJ SOL SYR, 5 ML per syringe, RXQ Compound... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | ONDANSETRON 2 MG/ML INJECTION SOLUTION (NPF), 20ML per vial, RXQ Compounding,... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | GLUTATHIONE 200MG/ML (PFV) INJECTION SOLN, 10 ML per vial, RXQ Compounding, 3... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
| Jun 19, 2019 | PHENYLEPHRINE HCL 100 MCG/ML IN NACL 0.9% SYR, 10 ML per syringe, RXQ Compoun... | Lack of Assurance of Sterility | Class II | RXQ Compounding LLC |
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.