Browse Drug Recalls
399 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 399 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 399 FDA drug recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Phenoxybenzamine Hydrochloride Capsules, USP 10mg, 100-count bottles, RX only... | Failed Impurities/Degradation Specifications | Class II | Par Formulations Private Limited |
| Dec 31, 2021 | Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distrib... | Complaint received of foreign matter (metal) embedded in tablet. | Class II | Rubicon Research Private Limited |
| Aug 12, 2021 | Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (... | Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, the... | Class II | ANHUI WELCOME FOREIGN TRADE CO.,LTD. |
| May 11, 2021 | DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.... | CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... | Class II | DIBAR NUTRICIONAL S DE RL DE CV |
| May 11, 2021 | ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by... | CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... | Class II | DIBAR NUTRICIONAL S DE RL DE CV |
| May 11, 2021 | ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002... | CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... | Class II | DIBAR NUTRICIONAL S DE RL DE CV |
| May 11, 2021 | DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distribut... | Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label c... | Class I | DIBAR NUTRICIONAL S DE RL DE CV |
| Mar 17, 2021 | Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: A... | Labeling: Label-mixup | Class I | Alembic Pharmaceuticals Limited |
| Dec 8, 2020 | Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: ... | CGMP Deviations | Class II | Shilpa Medicare Limited |
| Dec 8, 2020 | Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must... | CGMP Deviations | Class II | Shilpa Medicare Limited |
| Dec 8, 2020 | Docetaxel Injection USP 160 mg/8mL (20 mg/mL), For Intravenous Infusion Only,... | CGMP Deviations | Class II | Shilpa Medicare Limited |
| Dec 8, 2020 | Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use O... | CGMP Deviations | Class II | Shilpa Medicare Limited |
| Dec 8, 2020 | Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: ... | CGMP Deviations | Class II | Shilpa Medicare Limited |
| Dec 8, 2020 | Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use O... | CGMP Deviations | Class II | Shilpa Medicare Limited |
| Dec 1, 2020 | Pristine gel Hand Sanitizer Gel Antibacterial Gel Moisturizing, 8.45 Fl. Oz. ... | cGMP deviations: Product made at the same facility where product tested was sub-potent. | Class II | GAZA PROVEEDORA DE SERVICIOS DE HOSPEDAJE Y ALI... |
| 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. |
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.