Browse Drug Recalls
378 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 378 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 378 FDA drug recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 1, 2020 | Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Mad... | cGMP deviations: Product made at the same facility where product tested was sub-potent. | Class II | GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALI... |
| Nov 25, 2020 | UVT World Gel Hand Sanitizer 70% Alcohol Content, 33.9 FL OZ (1LT), Distribut... | Subpotent drug | Class II | Simex Logistics SA de CV |
| Nov 25, 2020 | Health & Hand Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distri... | Subpotent drug | Class II | Simex Logistics SA de CV |
| Nov 25, 2020 | Lavar 70 Gel Hand Sanitizer 70% Alcohol Content, 33.8 FL OZ (1L), Distributed... | Subpotent drug | Class II | Simex Logistics SA de CV |
| Nov 25, 2020 | +Protec Hands Antibacterial Gel Topical Solution Instant Sanitizer Hands 70% ... | Subpotent drug | Class II | Simex Logistics SA de CV |
| Nov 25, 2020 | CitruGel Hand Sanitizer Advanced Formula 70% Alcohol Fresh Lemon Scent, 33.81... | Subpotent drug | Class II | Simex Logistics SA de CV |
| Nov 20, 2020 | Scandonest 3% Plain (Mepivacaine Hydrochloride 3% without Vasoconstrictor), p... | Labeling: Label mix-up | Class III | Novocol Pharmaceutical of Canada, Inc. |
| Oct 2, 2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended Release Tablets USP 750 ... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | Marksans Pharma Limited |
| Oct 2, 2020 | Chlorhexidine Gluconate 20% 0012 Medichem, S.A. NDC 53296-0012-0 | Discoloration. | Class II | Medichem S.A. |
| Oct 2, 2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets USP 500... | CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... | Class II | Marksans Pharma Limited |
| Sep 11, 2020 | Killz Germz Hand Sanitizer, Alcohol Gel, 450 mL (15 fl oz.) bottle, Manufactu... | Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol lev... | Class II | Genesis Partnership Company SA |
| Sep 11, 2020 | Killz Germz Hand Sanitizer, Alcohol Gel, 1 Gallon (128 fl. oz.) bottle, Manuf... | Sub-Potent Drug; Killz GERMz was recalled due to sub-potent results. Testing revealed ethanol lev... | Class II | Genesis Partnership Company SA |
| Sep 11, 2020 | Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 240 mL (8... | CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facilit... | Class II | Genesis Partnership Company SA |
| Sep 11, 2020 | Panagel Hand Sanitizer, 70% Alcohol,16 Fl. Oz. (472 mL) bottle, Made in Guate... | CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facilit... | Class II | Genesis Partnership Company SA |
| Sep 11, 2020 | Genesis Hand Sanitizer Gel, Topical Solution, Non Sterile Solution, 1 gallon ... | CGMP Deviations: hand sanitizers were recalled because they were manufactured in the same facilit... | Class II | Genesis Partnership Company SA |
| Aug 25, 2020 | Protz real protection Antibacterial Hand Sanitizer, Ethyl Alcohol 70%, 13.5 F... | Lack of CGMPs: | Class II | Asiaticon, SA de CV |
| Aug 25, 2020 | V-Klean Hand Sanitizer Gel Alcohol 70% packaged as a)8.5 fl oz (250 ml), UPC... | Lack of CGMPs: | Class II | Asiaticon, SA de CV |
| Aug 18, 2020 | Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in 25 kg... | GMP Deviations: Potential to contain 1-propanol. | Class II | Nanomateriales Sa De Cv |
| Aug 18, 2020 | Zanilast+ Gel Antiseptic Hand Sanitizer (70% Ethyl Alcohol) Packaged in a) 33... | GMP Deviations: Potential to contain 1-propanol. | Class II | Nanomateriales Sa De Cv |
| Aug 18, 2020 | Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufact... | cGMP Deviations | Class II | GRUPO YACANA MEXICO SAS DE CV |
| Aug 18, 2020 | Yacana Alcohol Antiseptic 70% Topical Solution 8.5 oz (250 mL), OTC, Manufact... | cGMP Deviations | Class II | GRUPO YACANA MEXICO SAS DE CV |
| Aug 14, 2020 | Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a)... | CGMP Deviations: All other lots are being recalled because they were manufactured under the same ... | Class II | Grupo Asimex de Mexico SA de CV |
| 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 | Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufacture... | Failed Tablet/Capsule Specification; complaint of bulging tablet | Class II | Hetero Labs Limited (Unit V) |
| 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 31, 2020 | Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged ... | cGMP deviations | Class II | Laboratorios Jaloma S.A. de C.V. |
| Jul 30, 2020 | Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 ... | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... | Class II | Albek De Mexico S.A. De C.V. |
| Jul 30, 2020 | NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ... | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... | Class II | Albek De Mexico S.A. De C.V. |
| Jul 30, 2020 | NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcoho... | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... | Class II | Albek De Mexico S.A. De C.V. |
| Jul 30, 2020 | Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol ... | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... | Class II | Albek De Mexico S.A. De C.V. |
| Jul 30, 2020 | Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 ... | CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... | Class II | Albek De Mexico S.A. De C.V. |
| Jul 27, 2020 | HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as ... | CGMP Deviations: products were recalled because they were manufactured in the same facility as th... | Class II | Broncolin, S.A. de C.V. |
| 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 | scent theory KEEP IT CLEAN, pure clean,(Ethyl Alcohol 70%), 16.9 FL OZ/500 mL... | CGMP Deviations: Other products were recalled because they were manufactured in the same facility... | Class II | Real Clean Distribuciones SA de CV |
| Jul 23, 2020 | BORN BASIC., ANTI-BAC HAND SANITIZER, 70% Alcohol, (Ethyl Alcohol 70%), packa... | CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content an... | Class II | Real Clean Distribuciones SA de CV |
| Jul 23, 2020 | LUX EOI Hand Sanitizing Gel, (Ethyl Alcohol 70%), (16.9 FL OZ) 500mL bottle, ... | CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content an... | Class II | Real Clean Distribuciones SA de CV |
| 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 23, 2020 | scent theory KEEP CLEAN Moisturizing Hand Sanitizer, 70% alcohol (Ethyl Alcoh... | CGMP Deviations: Born Basic Anti Bac was found to be below the label claim for ethanol content an... | Class II | Real Clean Distribuciones SA de CV |
| 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 14, 2020 | Bersih Hand Sanitizer Gel, Net wt. 16.9 floz (500ml), Blue and Green cap) Dis... | cGMP Deviations | Class II | Soluciones Cosmeticas, SA de CV |
| Jul 2, 2020 | bio aaa Advance Hand Sanitizer Ethyl Alcohol 70%, Unscented, 16.23 Oz (480 mL... | CGMP Deviations | Class II | AAA Cosmetica, SA de CV |
| 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 |
| 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 10, 2020 | Aripiprazole Tablets, USP, 2 mg, 30 Tablets per bottle, Rx only, Manufactured... | Labeling: Label mix up: Bottles labeled as aripiprazole 2 mg, 30 count had aripiprazole 5 mg tabl... | Class II | Alembic Pharmaceuticals Limited |
| Jun 5, 2020 | Time-Cap Labs, Inc. Metformin Hydrochloride Extended-Release Tablets, USP 500... | CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... | Class II | Marksans Pharma Limited |
| May 19, 2020 | LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in ... | CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... | Class II | Wuhan Bingbing Pharmaceutical Co., Ltd. |
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.