Browse Drug Recalls
136 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 136 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 136 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 16, 2023 | Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx onl... | Packaging defect: blister packaging inadequately sealed. | Class II | The Harvard Drug Group |
| May 31, 2023 | ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx on... | Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg we... | Class I | The Harvard Drug Group LLC dba Major Pharmaceut... |
| Apr 24, 2023 | Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablet... | Product mixup: one foreign tablet found in product. | Class III | The Harvard Drug Group |
| Feb 23, 2023 | Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx ... | Packaging defect: observed packaging defect, blister packaging inadequately sealed. | Class II | The Harvard Drug Group |
| Jul 15, 2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 F... | CGMP Deviations | Class II | Vi-Jon, LLC |
| Jun 7, 2022 | GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 c... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg M... | Microbial Contamination of Non-Sterile Products. | Class I | Plastikon Healthcare LLC |
| Jun 7, 2022 | GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 ... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged... | Microbial Contamination of Non-Sterile Products | Class I | Plastikon Healthcare LLC |
| Jun 7, 2022 | Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg p... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cup... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg p... | Microbial Contamination of Non-Sterile Products. | Class I | Plastikon Healthcare LLC |
| Jun 7, 2022 | MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged... | Microbial Contamination of Non-Sterile Products. | Class I | Plastikon Healthcare LLC |
| Jun 7, 2022 | Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cup... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg M... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 ... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per ... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 c... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cu... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Mar 24, 2022 | MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packag... | CGMP Deviations: Failure to properly investigate failed microbial testing. | Class II | Plastikon Healthcare LLC |
| Mar 24, 2022 | Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 ... | CGMP Deviations: Failure to properly investigate failed microbial testing. | Class II | Plastikon Healthcare LLC |
| Mar 24, 2022 | Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per ... | CGMP Deviations: Failure to properly investigate failed microbial testing. | Class II | Plastikon Healthcare LLC |
| Mar 24, 2022 | MILK OF MAGNESIA USP, (Magnesium Hydroxide), 2400 mg/30 mL, 30 mL cup, packag... | Microbial Contamination of Non-Sterile Products | Class I | Plastikon Healthcare LLC |
| Mar 24, 2022 | Magnesium Hydroxide 1200mg, Aluminum Hydroxide 1200mg, Simethicone 120mg, 30 ... | Microbial Contamination of Non-Sterile Products | Class I | Plastikon Healthcare LLC |
| Feb 28, 2022 | PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 ... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| Feb 24, 2022 | hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister pa... | Failed Impurities/Degradation Specifications: Out of specification result obtained during routine... | Class II | The Harvard Drug Group |
| Oct 26, 2021 | Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1... | CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from th... | Class II | Perrigo Company PLC |
| Oct 12, 2021 | Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate... | Failed Moisture Limits | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 5, 2021 | Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S... | Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it ... | Class III | A-S Medication Solutions LLC. |
| Aug 6, 2021 | Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx onl... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| Aug 3, 2021 | Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distribute... | Failed Impurities/Degradation Specifications | Class II | The Harvard Drug Group |
| Jul 29, 2021 | Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, D... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| Jul 27, 2021 | MAJOR, Fexofenadine Hydrochloride tablets, 12HR, 60mg Antihistamine, 100 coun... | Failed Impurities/Degradation Specifications; Out of specification result obtained for impurity A... | Class II | Perrigo Company PLC |
| Jul 2, 2021 | NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 cou... | Failed Dissolution Specification: Out of specification for dissolution during routine stability t... | Class II | The Harvard Drug Group |
| Mar 15, 2021 | Banophen Diphenhydramine HCl 25 mg Antihistamine 100 capsules NDC 0904-5306-... | CGMP Deviations: Intermittent exposure to temperature excursion during storage. | Class II | Cardinal Health Inc. |
| Mar 2, 2021 | Acetaminophen, Extra Strength, Aspirin Free, 500 MG Tablets, 100-count bottle... | Labeling: Label Mix-up; The bottle of over-the-counter Acetaminophen 500mg Extra Strength, 100 co... | Class I | A-S Medication Solutions LLC. |
| Nov 18, 2020 | Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, M... | Failed Dissolution Specifications: Out of specification for dissolution. | Class II | The Harvard Drug Group |
| Jun 12, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (1... | CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established... | Class II | The Harvard Drug Group |
| May 22, 2020 | Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose carto... | Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf l... | Class II | The Harvard Drug Group |
| Apr 24, 2020 | Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per un... | Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine st... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dos... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Q... | Class III | The Harvard Drug Group |
| Feb 3, 2020 | Major Extra Strength Acetaminophen Tablets, 500 mg Pain Reliever/Fever Reduce... | Presence of Foreign Tablets/Capsules: Complaint involving one Women's Prenatal dietary supplement... | Class II | Contract Pharmacal Corporation |
| Dec 13, 2019 | Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-coun... | Failed Dissolution Specifications: High out of specification result observed at stability studies. | Class III | The Harvard Drug Group |
| Sep 18, 2019 | Major Infants' Gas Relief Drops, Simethicone Oral Suspension USP, 1 FL OZ (30... | Microbial Contamination of Non-Sterile Product. | Class II | GCP Laboratories Inc |
| Aug 30, 2019 | Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit ... | Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerob... | Class I | Plastikon Healthcare 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.