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 |
|---|---|---|---|---|
| Dec 17, 2020 | Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in ... | Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with th... | Class II | CIPLA |
| Nov 17, 2020 | Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg / 50 mL (4 mcg... | Cross Contamination with other products: trace amounts of lidocaine | Class I | Fresenius Kabi USA, LLC |
| Nov 17, 2020 | REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (... | Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated wit... | Class I | MPM Medical LLC |
| Nov 17, 2020 | Kollidon CL-M Crospovidone Ph.Eur.Type B, USP/NF, JP, micronized, packaged in... | Cross contamination: the excipient was found to be contaminated with theophylline. | Class II | BASF Corporation |
| Nov 17, 2020 | DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill... | Cross Contamination with Other Products: trace amounts of octreotide found during testing | Class III | Fresenius Kabi USA, LLC |
| Oct 28, 2020 | Chlorhexidine Gluconate Oral Rinse USP, 0.12%, Alcohol Free, packaged in 15 m... | Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer ... | Class I | Lohxa LLC |
| Oct 27, 2020 | Paroex (chlorhexidine gluconate) Oral Rinse, USP 0.12%, Alcohol Free, Rx only... | Microbial Contamination of Non-sterile Products: contamination with Burkholderia lata. | Class I | Sunstar Americas, Inc. |
| Sep 25, 2020 | Cord Care POWDER, 0.25 oz. (7 g) plastic jars, Wishgarden Herbs, Inc., Boulde... | Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. | Class I | Wishgarden Herbs, Incorporated |
| Sep 25, 2020 | Goldenseal POWDER, 0.25 oz. (7 g) plastic jars, WishGarden Herbs, Inc., Bould... | Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. | Class I | Wishgarden Herbs, Incorporated |
| Sep 25, 2020 | Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO... | Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii. | Class I | Wishgarden Herbs, Incorporated |
| Sep 9, 2020 | M Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,7... | Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and bel... | Class I | MEDEK LLC |
| Aug 17, 2020 | Goldenseal Root Powder Organic, 1 oz. clear plastic bag, Maison Terre Natural... | Microbial Contamination of Non-Sterile Products: FDA laboratory analysis found product to be cont... | Class I | Maison Terre, LLC |
| Aug 14, 2020 | Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a)... | Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-... | Class I | Grupo Asimex de Mexico SA de CV |
| Aug 6, 2020 | Incredible Products Gelbac T Antibacterial Hand Gel (ethyl alcohol 80%), Kill... | Chemical Contamination: Product contains methanol as an active ingredient and is sub-potent for e... | Class I | Incredible Products, SA de CV |
| Aug 4, 2020 | Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 FL OZ 250... | CGMP Deviation: Potential contamination with undeclared methanol. | Class II | ROQUE PLAST, S.A. DE C.V. |
| Jul 29, 2020 | Heparin Sodium 5,000 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 29, 2020 | Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Conta... | Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... | Class I | SCA Pharmaceuticals |
| 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 29, 2020 | Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Cont... | 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 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, (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) 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 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 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 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 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 | 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 6, 2020 | Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx ... | Cross contamination with other products - OOS discovered during routine stability testing for hig... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| 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 | 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 | Tasty Drops, Hemp Oil Extract, Natural, 1500MG CBD, 1 FL. OZ (30ML) bottles, ... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Goodness Gurus, Healthy Hemp Drops, 500MG/Spearmint, 1 FL. OZ bottles, Distri... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Tasty Drops, Hemp Oil Extract, Vanilla, 500MG CBD, 1 FL. OZ (30ML) bottles, D... | 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 | 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 | 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 | 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 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Spearmint, 500mg CBD, 1 FL.... | 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 | 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 | Recovery Releaf, Pure CBD Oil, Vanilla, 1000MG, 25MG per serving, 1 fl. oz (3... | 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 |
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.