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 5, 2026.
1,016of 1,016 medicine recallsshown with your filters
The list
- Medicine recall BENZALKONIUM CHLORIDE 0.013% SOLUTION Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall CALCIUM GLUCONATE 10% INJ (PF) Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall FOLIC ACID 10MG/ML MDV INJ Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall METHYLCOBALAMIN 10,000MCG/ML MDV INJ Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall METHYLCOBALAMIN 1000MCG/ML MDV INJ Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall METHYLCOBALAMIN 5000MCG/ML MDV INJ Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall MIC 25/50/50MG/ML MDV Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall MIT/B12 25/50/50MG/ML 1MG/ML MDV Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall PROGESTERONE 100MG/ML MDV OIL INJECTION Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall SODIUM SELINITE 200MCG/ML FOR INJ Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class IIFDA’s classNov 3, 2021in FDA’s Enforcement Report7 statesnamed in where it went PublishedNov 3, 2021ClassClass IIStatusTerminatedWhereArizona, California, Florida, Minnesota, Montana, Texas and Utah
- Medicine recall Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP… Failed Moisture Limits Class IIIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg),… Failed Moisture Limits Class IIIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Class IIIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Class IIIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg)… Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Class IIIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Class IIIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg)… Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Class IIIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per… Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Class IIIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2… Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Class IIIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets,… Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid. Class IIIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Rizatriptan Benzoate Film Coated Tablets, 10 mg Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples. Class IIIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples. Class IIIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples. Class IIIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 3, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration. Class IIIFDA’s classNov 3, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 3, 2021ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08% Chemical contamination; presence of benzene FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08% Chemical contamination; presence of benzene FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08% Chemical contamination; presence of benzene FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08% Chemical contamination; presence of benzene FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5% Chemical contamination; presence of benzene FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08% cGMP Deviations Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08% cGMP Deviations Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08% cGMP Deviations Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Cleaning Solutions Foaming Hand Sanitizer, Active Ingredient Benzalkonium chloride 0.1%, New Wave Cleaning… CGMP Deviations: Use of this product may cause possible infection/ irritation of the skin and/or soft tissues. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNevadathe one state its words name PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNevada
- Medicine recall Rocuronium Bromide Injection 50mg/5 mL, 5mL Multi-Dose Vial Labeling: Label Lacks Warning or Rx Legend: Finished product did not include the statement on the flip cap vial, “WARNING: PARALYZING AGENT” Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets Failed Dissolution Specifications: results were above specification. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not… Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not… Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count… CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Imipramine Pamoate Capsules 125 mg, 30-count bottle Out of specification result observed in a dissolution test at the 9-month long term stability time point. Class IIFDA’s classOct 27, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 27, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium Chloride Extended-Release Tablets, USP 10 mEq Failed Dissolution Specifications Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Potassium Chloride 40 mEq Lack of Assurance of Sterility Class IIFDA’s classOct 20, 2021in FDA’s Enforcement ReportMissourithe one state its words name PublishedOct 20, 2021ClassClass IIStatusTerminatedWhereMissouri
- Medicine recall Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 20, 2021in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 20, 2021ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
Nothing matches all of these.
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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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