Browse Drug Recalls
2,138 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 2,138 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 2,138 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 27, 2023 | Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solutio... | Chemical Contamination: FDA testing found Presence of methanol | Class I | Jarman's Midwest Cleaning Systems, Inc. |
| Mar 27, 2023 | Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-... | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 27, 2023 | SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STER... | Chemical Contamination: FDA testing found Presence of methanol | Class I | Jarman's Midwest Cleaning Systems, Inc. |
| Mar 27, 2023 | Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-75... | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 27, 2023 | Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharma... | CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk o... | Class II | Preferred Pharmaceuticals, Inc. |
| Mar 22, 2023 | Alprazolam C-IV, 0.5 mg, 30 Tabs per bottle, Rx only, Packaged and Distribute... | CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns... | Class II | Direct Rx |
| Mar 22, 2023 | Alprazolam C-IV, 2 mg, 60 Tabs per bottle, Rx only, Packaged and Distributed ... | CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns... | Class II | Direct Rx |
| Mar 22, 2023 | Alprazolam C-IV, 1 mg, packaged in a) 30 Tabs per bottle, NDC 72189-213-30; b... | CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns... | Class II | Direct Rx |
| Mar 13, 2023 | Atovaquone Oral Suspension USP, 750 mg/5 mL, Packaged in 210 mL bottle, Manuf... | Microbial Contamination of Non-Sterile Product: Objectionable organism, identified as Bacillus ce... | Class I | Camber Pharmaceuticals Inc. |
| Mar 2, 2023 | Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Cent... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Cent... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 5199... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 5... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 519... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Feb 14, 2023 | Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-S... | Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and ace... | Class I | Nanomaterials Discovery Corporation |
| Jan 30, 2023 | Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Ey... | Non-Sterility: FDA analysis found unopened products to have bacterial contamination. | Class I | Global Pharma Healthcare Private Limited |
| Jan 30, 2023 | Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG i... | Non-Sterility: FDA analysis found unopened products to have bacterial contamination. | Class I | Global Pharma Healthcare Private Limited |
| Dec 23, 2022 | Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hyd... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Adventure First Aid 1.0, First Aid Kit, containing Easy Care first aid After ... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care ... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care ... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | CVS First Aid Home, First Aid Kit, containing Easy Care first aid After Burn ... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Easy Care First Aid 10 Person 2009 ANSI, First Aid Kit, containing Easy Care ... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Easy Care First Aid 25 Person 2009 ANSI, First Aid Kit, containing Easy Care ... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Adventure First Aid 1.5, First Aid Kit, containing Easy Care first aid After ... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Easy Care First Aid Class A ANSI 25 Person, First Aid Kit, containing Easy Ca... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Dec 23, 2022 | Adventure Marine 150, First Aid Kit, containing Easy Care first aid After Bur... | Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be conta... | Class I | GFA Production Xiamen Co. Ltd. |
| Nov 10, 2022 | PF-Labetalol HCl Injection, USP 20 mg/4 mL (5 mg/mL) vial, Rx Only, Nephron 5... | CGMP Deviations: Potential for cross contamination due to product carry over. | Class II | Nephron Sterile Compounding Center LLC |
| Nov 10, 2022 | PF-Neostigmine Methylsulfate Injection, USP 3 mg/3 mL (1 mg/mL) vial, Rx Only... | CGMP Deviations: Potential for cross contamination due to product carry over. | Class II | Nephron Sterile Compounding Center LLC |
| Nov 5, 2022 | Adam's Polishes ALCOHOL BASED HAND SANITIZER, isopropyl alcohol 75% v/v, pack... | Chemical Contamination: FDA analysis found 1 lot of Adam's Polishes ALCOHOL BASED HAND SANITIZER ... | Class I | Adam's Polishes LLC |
| Sep 14, 2022 | Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) ... | Chemical Contamination: product found to contain benzene | Class I | Salon Technologies International Inc |
| Aug 15, 2022 | Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99... | Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the compone... | Class II | Ultra Chem Labs Corp |
| Aug 15, 2022 | Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99... | Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the compone... | Class II | Ultra Chem Labs Corp |
| Aug 10, 2022 | Trisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mm... | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. | Class II | Nephron Sterile Compounding Center LLC |
| Aug 10, 2022 | PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL ... | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. | Class II | Nephron Sterile Compounding Center LLC |
| Aug 10, 2022 | Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL... | cGMP Deviations: deviations leading to potential cross-contamination. | Class II | Nephron Sc Inc |
| Aug 10, 2022 | PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Via... | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. | Class II | Nephron Sterile Compounding Center LLC |
| Aug 10, 2022 | PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Un... | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. | Class II | Nephron Sterile Compounding Center LLC |
| Jul 29, 2022 | Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.... | Chemical contamination: presence of benzene | Class I | Edgewell Personal Care Brands, LLC |
| Jul 15, 2022 | equate Magnesium Citrate, SALINE LAXATIVE, (1.745g/fl oz) 10 FL OZ (296mL), G... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | EQUALINE magnesium citrate saline laxative, oral solution, (1.745 g/fl oz), D... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Topcare health, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/f... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.74... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz)... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Rexall, Magnesium Citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Le... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl ... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | meijer, magnesium citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Le... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | P, magnesium citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Lemon F... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Kroger, Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flav... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, 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.