Browse Drug Recalls
2,165 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,165 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 2,165 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 18, 2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Berry Blast, 500mg CBD, 1 F... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Apr 15, 2020 | KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By ... | Chemical Contamination; product contains elevated levels of lead | Class I | Summitt Labs |
| Apr 14, 2020 | Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Com... | Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain m... | Class I | MasterPharm LLC |
| Mar 19, 2020 | Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lot... | Microbial contamination of non-sterile products: positive test for yeast and bacteria. | Class II | Filltech USA, LLC |
| Mar 19, 2020 | Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lot... | Microbial contamination of non-sterile products: positive test for yeast and bacteria. | Class II | Filltech USA, LLC |
| Jan 31, 2020 | Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed b... | Microbial Contamination of Non-Sterile Products | Class II | Efficient Laboratories, Inc. |
| Jan 31, 2020 | Rompe Pecho EX Expectorant, 6 FL. Oz (178 mL) bottle, Distributed by: Effici... | Microbial Contamination of Non-Sterile Products | Class II | Efficient Laboratories, Inc. |
| Jan 31, 2020 | New! Rompe Pecho MAX Multi Symptoms, 8 FL. Oz (237 mL) bottle, Distributed by... | Microbial Contamination of Non-Sterile Products | Class II | Efficient Laboratories, Inc. |
| Jan 7, 2020 | Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET W... | Microbial contamination of non-sterile product. | Class III | Sigan Industries Inc. |
| Dec 26, 2019 | Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper ... | Chemical contamination; out of specification results obtained for equipment cleaning residue rins... | Class III | Akorn, Inc. |
| Dec 20, 2019 | Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro P... | Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. | Class I | Taro Pharmaceuticals U.S.A., Inc. |
| Dec 6, 2019 | Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, D... | Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total ... | Class I | Lannett Company, Inc. |
| Nov 25, 2019 | Petroleum jelly (White Petrolatum) USP 100%, packaged in a) 1 oz tube (UPC 11... | Cross contamination with other products: undeclared contaminants of phenol and camphor in petrole... | Class II | OraLabs, Incorporated |
| Oct 31, 2019 | LETS GEL KIT Convenience Pack (To prepare 100 mL LETS GEL), Contains: LETS Po... | Microbial contamination of non-sterile product. | Class II | Fagron, Inc |
| Oct 23, 2019 | Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 60 tablets per ... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 90 t... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 8 tablets. [ND... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 95 tablets per... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 150 tablets per... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 65 t... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 65 tablets per... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 24 t... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 200 tablets pe... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 40 t... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 90 tablets per... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 160 tablets per... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 24 tablets per... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Maximum Strength Acid Reducer, Cool Mint Ranitidine tablets, USP 150 mg, 95 t... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 30 tablets per ... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Maximum Strength Acid Reducer, Ranitidine tablets, USP 150 mg, 50 tablets per... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 23, 2019 | Regular Strength Acid Reducer, Ranitidine tablets, USP 75 mg, 80 tablets per ... | CGMP Deviation; Possible contamination with impurity N-nitrosodimethylamine. | Class II | Perrigo Company PLC |
| Oct 9, 2019 | PF-Fentanyl Citrate 2 mcg/mL* & Ropivacaine HCl 0.1% in 0.9% Sodium Chloride ... | GMP Deviations: potential glass contamination | Class II | Nephron Pharmaceuticals Corporation dba Nephron... |
| Oct 9, 2019 | PF-Fentanyl Citrate (2 mcg/mL)* & Bupivacaine HCl 0.0625 in 0.9% Sodium Chlo... | GMP Deviations: potential glass contamination | Class II | Nephron Pharmaceuticals Corporation dba Nephron... |
| Oct 9, 2019 | PF-Fentanyl Citrate 2 mcg/mL* & Bupivacaine HCl 0.125% in 0.9% Sodium Chlorid... | GMP Deviations: potential glass contamination | Class II | Nephron Pharmaceuticals Corporation dba Nephron... |
| Sep 24, 2019 | Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Re... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Class II | Apotex Inc. |
| Sep 24, 2019 | Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Redu... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Class II | Apotex Inc. |
| Sep 24, 2019 | Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg-acid reduce... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Class II | Apotex Inc. |
| Sep 24, 2019 | Rite Aid Pharmacy Maximum Strength Ranitidine Tablets, USP 150 mg Cool Mint A... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Class II | Apotex Inc. |
| Sep 24, 2019 | Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer Cool Mint... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Class II | Apotex Inc. |
| Sep 24, 2019 | Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Table... | GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA). | Class II | Apotex Inc. |
| Sep 23, 2019 | DrKids Children's Natural Cough Syrup English Ivy Leaf, packaged in Pre-measu... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| Sep 23, 2019 | DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-... | CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination... | Class II | Unipharma, Llc. |
| 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 |
| Sep 12, 2019 | Fentanyl Citrate USP, Active Pharmaceutical Ingredient, Spectrum Chemical MFG... | CGMP Deviations: Received notice from supplier that there is potential glass contamination. | Class II | Spectrum Laboratory Products |
| 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 |
| Aug 29, 2019 | Oxaliplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical ... | cGMP Deviations: Potential glass contamination | Class II | Johnson Matthey Inc. |
| Aug 29, 2019 | Cisplatin Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceutical Ma... | cGMP Deviations: Potential glass contamination | Class II | Johnson Matthey Inc. |
| Aug 29, 2019 | Fentanyl Citrate Active Pharmaceutical Ingredient, Johnson Matthey Pharmaceut... | cGMP Deviations: Potential glass contamination | Class II | Johnson Matthey Inc. |
| Aug 14, 2019 | RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 ta... | Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas. | Class II | Pfizer Inc. |
| Aug 9, 2019 | PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged... | Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above... | Class II | Ridge Properties, 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.