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 Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramuscular injection Lack of Assurance of Sterility Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injection Lack of Assurance of Sterility Class IIFDA’s classJul 28, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 28, 2021ClassClass IIStatusCompletedWhereNationwide
- Medicine recall NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Failed Dissolution Specification: Out of specification for dissolution during routine stability testing. Class IIFDA’s classJul 21, 2021in FDA’s Enforcement Report2 statesnamed in where it went PublishedJul 21, 2021ClassClass IIStatusTerminatedWhereNew Jersey and Ohio
- Medicine recall B-Force, Homeopathic, 1 Fl Oz Superpotent Class IIIFDA’s classJul 21, 2021in FDA’s Enforcement ReportFloridathe one state its words name PublishedJul 21, 2021ClassClass IIIStatusTerminatedWhereFlorida
- Medicine recall Poseidon Platinum 3500 capsule, 1-count per blister card Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalafil making them unapproved drugs for which the safety and… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IStatusTerminatedWhereNo state named
- Medicine recall LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint. Class IIIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free Microbial Contamination of Non-Sterile Products: firm’s internal testing found certain lots of the product to be contaminated with Burkholderia contaminans… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 21, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13%, 160-count canister Microbial Contamination of Non-Sterile Products: firm’s internal testing found certain lots of the product to be contaminated with Burkholderia contaminans… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 21, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, listed as 0.1% or 0.13%, Alcohol-Free CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated. Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 21, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes, 0.13% CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the same conditions as product lots found to be contaminated. Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 21, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Solifenacin Succinate Tablets, 10 mg, 30-count bottles CGMP Deviations Class IIFDA’s classJul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 21, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 21, 2021in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 21, 2021ClassClass IStatusOngoingWhereNo state named
- Medicine recall Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitizer Hand sanitizer packaged in bottles that resemble beverage containers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 21, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 21, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each containing 1 sublingual film Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low) Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL Low out of specification results for epinephrine assay. Class IIFDA’s classJul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Topotecan Injection 4 mg/4mL Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 14, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 14, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Premium OrgaZEN 7000 capsule, 1-count per blister card Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Angeles, CA 90010 Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or tadalafil FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IStatusOngoingWhereNationwide
- Medicine recall QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ Subpotent Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label claim for ethanol content and to contain methanol. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%) CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ProtectoRx (ethyl alcohol 70%) CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufactured under the same conditions as the product lots found to… Class IIFDA’s classJul 7, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 7, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PremierZEN Gold 7000 capsule, 1-count blister card Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 30, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6) Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 30, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8) Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 30, 2021ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Diflorasone Diacetate Ointment USP, 0.05% Presence of Foreign Substance: Foreign particles observed during routine stability testing. Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper. Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Mephyton (Phytonadione) 5 mg tablets, 100-count tablets Failed Impurities/Degradation Specifications Class IIIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 30, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Phytonadione Tablets, 5 mg, 30-count ablets Failed Impurities/Degradation Specifications Class IIIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 30, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. Class IIFDA’s classJun 30, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 30, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beauty Technologies Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ingredients Sibutramine and Fluoxetine Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 23, 2021ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities Class IIIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 23, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Phytonadione Tablets 5 mg Failed Impurities Specification: Out of specification when measuring the impurity degradant D level. Class IIIFDA’s classJun 23, 2021in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedJun 23, 2021ClassClass IIIStatusTerminatedWhereCalifornia
- Medicine recall QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzhou Minghui Cosmetics Co., Ltd.,… Subpotent Class IIFDA’s classJun 23, 2021in FDA’s Enforcement ReportNew Yorkthe one state its words name PublishedJun 23, 2021ClassClass IIStatusTerminatedWhereNew York
- Medicine recall Ketamine HCl Injection Solution, 10 mg / 2 mL Labeling: Incorrect Exp. Class IIIFDA’s classJun 23, 2021in FDA’s Enforcement ReportSouth Carolinathe one state its words name PublishedJun 23, 2021ClassClass IIIStatusTerminatedWhereSouth Carolina
- Medicine recall Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451 Temperature Abuse: Product exposed to temperature outside specified limits. Class IIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack Temperature Abuse: Product exposed to temperature outside specified limits. Class IIIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low Calcium Temperature Abuse: Product exposed to temperature outside specified limits. Class IIIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius… Temperature Abuse: Product exposed to temperature outside specified limits. Class IIIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium and attached stay safe… Temperature Abuse: Product exposed to temperature outside specified limits. Class IIIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low Calcium and attached stay safe… Temperature Abuse: Product exposed to temperature outside specified limits. Class IIIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low Calcium and attached stay safe… Temperature Abuse: Product exposed to temperature outside specified limits. Class IIIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low Calcium Temperature Abuse: Product exposed to temperature outside specified limits. Class IIIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate. Class IIIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Levetiracetam Tablets USP, 250 mg UD 100 Tablets Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units being read as Naproxen Tablets 500 mg. Class IIIFDA’s classJun 16, 2021in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 16, 2021ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct Subpotent Drug Class IIFDA’s classJun 9, 2021in FDA’s Enforcement Report11 statesnamed in where it went PublishedJun 9, 2021ClassClass IIStatusTerminatedWhereArkansas, Colorado, Connecticut, Louisiana, North Carolina, North Dakota, New Hampshire, New Jersey, Ohio, Pennsylvania and Puerto Rico
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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