Medicines, 2021
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1,016 medicine recalls FDA’s Enforcement Report published in 2021, newest first; 18,075 in all since 2012.
FDA’s medicine recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
1,016of 1,016 medicine recallsshown with your filters
The list
- Medicine recall Arformoterol Tartrate Inhalation Solution 15 mcg*/2 mL For Oral Inhalation Only Lack of Assurance of Sterility Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Betadine Solution Swabstick Povidone-Iodine Solution USP, 10 % single and three count Antispetic Non-Sterile… Subpotent Drug Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Zonisamide 100 mg Capsules, 30-count bottles CGMP deviations: Gaps in the quality system in the Quality Control microbiology laboratory. Class IIFDA’s classSep 29, 2021in FDA’s Enforcement ReportFloridathe one state its words name PublishedSep 29, 2021ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC). FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 29, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 29, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Oxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%) Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 22, 2021ClassClass IStatusTerminatedWhereNationwide, and Florida named
- Medicine recall Florance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%) CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol. Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereNationwide, and Florida named
- Medicine recall Hydro Pinapple Burn Max Health Thach Dua Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles Failed Impurities/Degradation Specifications; out of specification for Related Compound Class IIIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on… Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles Superpotent Drug FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials Failed Impurities/Degradation Specifications Class IIIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Betamethasone Dipropionate Lotion USP (Augmented), 0.05% Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product. Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall MIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial… Lack of processing controls Class IIFDA’s classSep 22, 2021in FDA’s Enforcement Report5 statesnamed in where it went PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereArizona, Colorado, Florida, Illinois and New Jersey
- Medicine recall Spironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles Lack of Assurance of Sterility Class IIFDA’s classSep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples. FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 22, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 22, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution,… CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits. Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportMichiganthe one state its words name PublishedSep 15, 2021ClassClass IIStatusTerminatedWhereMichigan
- Medicine recall HAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution,… CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits. Class IIFDA’s classSep 15, 2021in FDA’s Enforcement ReportMichiganthe one state its words name PublishedSep 15, 2021ClassClass IIStatusTerminatedWhereMichigan
- Medicine recall QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ Subpotent Class IIFDA’s classSep 15, 2021in FDA’s Enforcement Report13 statesnamed in where it went PublishedSep 15, 2021ClassClass IIStatusTerminatedWhereAlabama, Connecticut, Florida, Louisiana, Massachusetts, Maine, Mississippi, North Carolina, New York, Rhode Island, South Carolina, Texas and Virginia
- Medicine recall Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cyclobenzaprine Hydrochloride Tablets, 7.5mg, 100 count tablets per bottle CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Naproxen Sodum Tablets USP 220 mg, (Caplet) CGMP Deviations Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNew York
- Medicine recall MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alcohol 70% v/v), 10 FL OZ / 300 mL CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 FL OZ Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA (ethyl alcohol 70%) to be below the label claim… FDA Class I, its most serious class Class IFDA’s class (needs attention)Sep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8.5 FL OZ / 250 mL bottle CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70% v/v), 8 Fl OZ CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to… Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Donepezil HCL Tablets, USP, 5 mg, 90-count bottle Subpotent Class IIIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine Ointment USP, 5% Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing. Class IIIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Artificial Tears Ointment, Lubricant Eye Ointment Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Clopidogrel Tablets, USP, 75 mg, 500-count bottle Presence of foreign matter Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. Class IIFDA’s classSep 8, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 8, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carvedilol 25 mg, 180-count bottle A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereFlorida and Virginia
- Medicine recall Pi yen chin Ophthalmic Redness Reliever Drops Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PDI Povidone-Iodine Prep Pad MEDIUM, 1 Prep Pad [2.0x2.5 in SubPotent: Out of Specification Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PDI Povidone-Iodine Prep Pad Large, 1 Prep Pad, Professional Disposable International, Inc., Orangeburg, NY… SubPotent: Out of Specification Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PDI Povidine Iodine Swabstick SubPotent: Out of Specification Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PDI Povidone-Iodine Swabstick SubPotent: Out of Specification Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PDI Povidone-Iodine Cleansing Scrub Swabstick SubPotent: Out of Specification Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PDI Povidone-Iodide Cleansing Scrub Swabstick SubPotent: Out of Specification Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PDI Duo-Swab Povidone-Iodine Cleansing Scrub Swabstick SubPotent: Out of Specification Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmental monitoring in aseptic areas of manufacturing. Class IIFDA’s classSep 1, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 1, 2021ClassClass IIStatusTerminatedWhereNationwide
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Source:
FDA, Drug recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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