Medicines, 2021
Shortlist up to four to read them side by side.
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 SUFENTANIL-BUPIVACAINE-BACLOFEN PF 25MCG-12.5MG-750MCG/ML INJECTABLE 41 mL syringe Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWherePuerto Rico and Texas
- Medicine recall MORPHINE-BUPIVACAINE-FENTANYL PF 30MG-15MG-2000MCG/ML INJECTABLE 21 mL syringe Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWherePuerto Rico and Texas
- Medicine recall HYDROMORPHONE HCL-BUPIVACAINE HCL-SUFENTANIL PF 25MG-9MG-110MCG/ML INJECTABLE 21 mL syringe Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWherePuerto Rico and Texas
- Medicine recall HYDROMORPHONE HCL-BUPIVACAINE HCL PF INJECTABLE 21 and 22 mL syringes in various strengths: a) 0.5MG-5MG/ML,… Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWherePuerto Rico and Texas
- Medicine recall C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People’s Custom Rx, Compounded Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 18, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedAug 18, 2021ClassClass IStatusTerminatedWhereMississippi and Tennessee
- Medicine recall Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets Presence of Foreign Substance- Potential of metal contamination. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement Report3 statesnamed in where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereIndiana, Mississippi and Ohio
- Medicine recall Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. Class IIFDA’s classAug 18, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 18, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 4 fl CGMP Deviations: Does not meet monograph for denaturant. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 11, 2021ClassClass IIStatusTerminatedWhereConnecticut, Massachusetts, Maine, North Dakota, New York, Oregon, Pennsylvania, Texas and Vermont
- Medicine recall Global Hand Sanitizer with moisturizer, Alcohol-based Antiseptic 80%, Non-sterile Topical Solution, 8 fl CGMP Deviations: Does not meet monograph for denaturant. Class IIFDA’s classAug 11, 2021in FDA’s Enforcement Report9 statesnamed in where it went PublishedAug 11, 2021ClassClass IIStatusTerminatedWhereConnecticut, Massachusetts, Maine, North Dakota, New York, Oregon, Pennsylvania, Texas and Vermont
- Medicine recall Chantix (varenicline) tablets, 0.5mg*, 56 Tablets CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Chantix (varenicline)Tablets, Contains: 1 Starting Week CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Chantix (varenicline) tablets, 1 mg, 56 Tablets CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acceptable intake limit Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 11, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Succinylcholine Chloride 100 mg/5 mL Lack of sterility assurance Class IIFDA’s classAug 11, 2021in FDA’s Enforcement ReportFloridathe one state its words name PublishedAug 11, 2021ClassClass IIStatusTerminatedWhereFlorida
- Medicine recall Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine. FDA Class I, its most serious class Class IFDA’s class (needs attention)Aug 11, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 11, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall Estriol USP41 Micro 25 Grams cGMP Deviations Class IIFDA’s classAug 4, 2021in FDA’s Enforcement Report5 statesnamed in where it went PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereAlabama, Arizona, Colorado, Florida and Virginia
- Medicine recall Azelaic Acid 99.0+% Micro 500 Grams cGMP Deviations Class IIFDA’s classAug 4, 2021in FDA’s Enforcement Report5 statesnamed in where it went PublishedAug 4, 2021ClassClass IIStatusTerminatedWhereAlabama, Arizona, Colorado, Florida and Virginia
- Medicine recall Krazy Night capsule Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Shogun-X capsules, 10-count boxes Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Thumbs up 7 Red 70K capsules, 10-count boxes Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each Labeling: Not Elsewhere Classified The primary label contains the words “enteric coated” but the tablet is not enteric coated and should only say ‘coated… Class IIIFDA’s classJul 28, 2021in FDA’s Enforcement ReportPennsylvaniathe one state its words name PublishedJul 28, 2021ClassClass IIIStatusTerminatedWherePennsylvania
- Medicine recall Ulta beauty Fresh Lemon Citron Frais, 70% Alcohol Hand Sanitizer Spray Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall SS Coconut Breeze Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall SS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall SS Lavender & Herbs Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall SS Tangerine & Guava Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Goose Creek Hand Sanitizer aloe Blueberry Limeade, Anti-Bacterial Spray, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Goose Creek Hand Sanitizer aloe Limoncello, Anti-Bacterial Spray, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Goose Creek Hand Sanitizer aloe Beach Dreams, Anti-Bacterial Spray, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Goose Creek Hand Sanitizer aloe Grape Soda, Anti-Bacterial Spray, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Goose Creek Hand Sanitizer aloe Champagne Bubbles, Anti-Bacterial Spray, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Goose Creek Hand Sanitizer aloe Marshmallows, Anti-Bacterial Spray, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Goose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Goose Creek Hand Sanitizer aloe Optimistic Vibes, Anti-Bacterial Spray, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Goose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Goose Creek Hand Sanitizer aloe Watermelon Lemonade, Anti-Bacterial Spray, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Goose Creek Hand Sanitizer aloe Tropical Daydream, Anti-Bacterial Spray, 3.38 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Coconut Stand CoCo TKO Hand Sanitizer, Totally Knocks Out 99.9% of Germs, 3.4 FL Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Shogun-X 7000 capsule Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall Thumbs Up 7 Black 25K capsule Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an FDA approved drug making this an unapproved drug for which the… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall Thumbs Up 7 White 11K capsule Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sildenafil, and vardenafil, FDA approved drugs making them an… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall 69MODE Blue 69 capsule Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making it an unapproved… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall Erythromycin Topical Solution USP, 2% 60 mL Failed Impurities/Degradation Specifications Class IIIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Erythromycin Topical Gel, 2% Failed Impurities/Degradation Specifications Class IIIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IIIStatusTerminatedWhereNationwide
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
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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