Browse Drug Recalls
1,749 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,749 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 1,749 FDA drug recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 29, 2020 | Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Contai... | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... | Class I | SCA Pharmaceuticals |
| Jul 27, 2020 | HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as ... | Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below ... | Class I | Broncolin, S.A. de C.V. |
| Jul 23, 2020 | BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), 16.9 ... | Chemical Contamination: Born Basic Anti Bac was found to be below the label claim for ethanol con... | Class I | Real Clean Distribuciones SA de CV |
| Jul 22, 2020 | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 m... | Cross Contamination with other products: trace amounts of lidocaine | Class I | Fresenius Kabi USA, LLC |
| Jul 21, 2020 | DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only... | Superpotent Drug | Class I | Ferring Pharmaceuticals Inc |
| Jul 21, 2020 | Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap... | Superpotent Drug | Class I | Ferring Pharmaceuticals Inc |
| Jul 21, 2020 | STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with s... | Superpotent Drug | Class I | Ferring Pharmaceuticals Inc |
| Jul 20, 2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 1 Gal (3.78 L)... | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Class I | Liq-E S.A. De C.V. |
| Jul 20, 2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 275 Gal (1040 L)... | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Class I | Liq-E S.A. De C.V. |
| Jul 20, 2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (alcohol 70% v/v) 55 Gal (208 L) d... | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Class I | Liq-E S.A. De C.V. |
| Jul 20, 2020 | OPTIMUS LUBRICANTS Instant Hand Sanitizer, (ethyl alcohol 70%) 8.5 Fl. Oz. (... | Chemical Contamination: Products contain methanol and were below the label claim for ethanol content | Class I | Liq-E S.A. De C.V. |
| Jul 11, 2020 | blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v... | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... | Class I | 4e Brands North America, Llc |
| Jul 11, 2020 | blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost ... | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... | Class I | 4e Brands North America, Llc |
| Jul 11, 2020 | blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) P... | Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below th... | Class I | 4e Brands North America, Llc |
| Jul 7, 2020 | ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV reg... | Class I | CareFusion 213, LLC |
| Jul 7, 2020 | BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the la... | Class I | CareFusion 213, LLC |
| Jul 7, 2020 | BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... | Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the la... | Class I | CareFusion 213, LLC |
| Jul 7, 2020 | ChloraPrep One-Step 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropy... | Microbial Contamination of Non-Sterile Product: Product is being recalled to climatic Zone IV reg... | Class I | CareFusion 213, LLC |
| Jul 7, 2020 | Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Ma... | Presence of Particulate Matter | Class I | Mylan Institutional LLC |
| Jul 2, 2020 | bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL... | Chemical Contamination: Product contains methanol. | Class I | AAA Cosmetica, SA de CV |
| 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 29, 2020 | Mystic Shield PROTECTION, ALCOHOL ANTISEPTIC 70%, Topical Solution, Antisepti... | Chemical Contamination: Presence of Undeclared Methanol | Class I | Transliquid Technologies, LLC |
| Jun 24, 2020 | Chlorhexidine Gluconate 0012 For Manufacturing, Processing or Repacking, RX O... | Microbial contamination of Non-Sterile Product; detection of the gram-negative bacillus Serratia... | Class I | Medichem S.A. |
| Jun 23, 2020 | ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | Class I | CareFusion 213, LLC |
| Jun 23, 2020 | BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) an... | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | Class I | CareFusion 213, LLC |
| Jun 23, 2020 | ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... | Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides | Class I | CareFusion 213, LLC |
| Jun 23, 2020 | All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%,... | Chemical Contamination: Product contains undeclared methanol. | Class I | Itech 361 LLC |
| Jun 22, 2020 | Saniderm ADVANCED HAND SANITIZER, 70% Alcohol Content, 1 Liter bottles, Distr... | Chemical Contamination: Product contains undeclared methanol. | Class I | UVT INC |
| Jun 18, 2020 | Acadia Farms, Serenity, soothing mint, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bottl... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Made by Hemp 1000MG Hemp Extract, Mojito Lime, 1 OZ (30 ML) bottles, Dist by:... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Tasty Drops, Hemp Oil Extract, Spearmint, 1500MG CBD,1 FL. OZ (30ML) bottles,... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Javan Anti Aging and Wellness Institute, CBD Oil, Full Spectrum Hemp Oil, Spe... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | A Clean Choice CBD, Hemp Oil Extract Tincture, Strawberry Creme, 1000mg, 1 fl... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural, 1000MG CBD, 1 FL. ... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil , Berry Blast, 1000MG CBD, 1... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Goodness Gurus, Healthy Hemp Drops, 1500 MG/Spearmint, 1 FL. OZ bottles, Dist... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Tasty Drops Hemp Oil Extract, Natural, 1 FL. OZ (30ML) bottles, 500mg CBD, Di... | Chemical Contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Goodness Gurus, Healthy Hemp Drops, 500MG/Berry, 1 FL. OZ bottles, Distribute... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Pathway To Wellness, CBD Oil, Premium Hemp Oil Drops, Natural, 1000MG CBD, 1 ... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Acadia Farms, Equilibrium, vermont maple, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bo... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Tasty Drops Hemp Oil Extract, Berry, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Tasty Drops, Hemp Oil Extract, Spearmint, 1000MG CBD, 1 FL. OZ (30ML) bottles... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Tasty Drops, Hemp Oil Extract, Berry, 500MG CBD, 1 FL. OZ (30ML) bottles, Dis... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural 500MG CBD, 1 FL. OZ... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Tasty Drops, Hemp Oil Extract, Spearmint, 500MG CBD, 1 FL. OZ (30ML) bottles,... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Herbzeedy, Hemp Oil Full Spectrum, Natural, 500 MG CBD, 1 FL OZ (30 ML) bottl... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | A Clean Choice CBD, Hemp Oil Extract Tincture, French Vanilla, 1000 mg, 1 fl ... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Tasty Drops Hemp Oil Extract, Vanilla, 1 FL. OZ (30ML) bottles, 300MG CBD, Di... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | SP, hemp oil, Berry, 300MG CBD,1 FL. OZ (30 ML) bottles, Distributed by: The ... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Herbzeedy, Hemp Oil Full Spectrum, Natural, 1500 MG CBD, 1 FL OZ (30 ML) bott... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
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.