Medicines, 2023
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1,252 medicine recalls FDA’s Enforcement Report published in 2023, 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.
1,252of 1,252 medicine recallsshown with your filters
The list
- Medicine recall Fentanyl 500mcg Lack of assurance of sterility: Suspected microbial growth present on external label packaging. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportMissourithe one state its words name PublishedApr 5, 2023ClassClass IIStatusOngoingWhereMissouri
- Medicine recall Dabigatran Etexilate Capsules, 75 mg CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dabigatran Etexilate 150mg Capsules, 150 mg CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. Class IIFDA’s classApr 5, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 5, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall JARDIANCE (Empagliflozin), 25 mg Tablets Labeling: Label Mix-up Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 29, 2023ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Daytrana (methylphenidate transdermal system) CII, 10mg, 30-count carton Defective Delivery System: Out of specification for shear. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system) CII, 15 mg, 30-count carton Defective Delivery System: Out of specification for shear. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system) CII, 20mg, 30-count carton Defective Delivery System: Out of specification for shear. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton Defective Delivery System: Out of specification for shear. Class IIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Dofetilide Capsules, 500 mcg Failed Content Uniformity Specifications Class IIIFDA’s classMar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Delsam Pharma’s Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 29, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 29, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Alprazolam Tablets, USP, 0.25mg, CIV CGMP Deviations: Potential risk of Cross Contamination Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprazolam Tablets, USP, 0.5mg, CIV CGMP Deviations: Potential risk of Cross Contamination Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprazolam Tablets, USP, 1 mg, CIV CGMP Deviations: Potential risk of Cross Contamination Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprazolam Tablets, USP, 2 mg, CIV CGMP Deviations: Potential risk of Cross Contamination Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clobazam Tablets, 10 mg, CIV, 100-count bottle CGMP Deviations: Potential risk of Cross Contamination Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clobazam Tablets, 20 mg, CIV, 100-count bottle CGMP Deviations: Potential risk of Cross Contamination Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Evamist (estradiol transdermal spray), 1.53 mg of estradiol per spray, 0.27 fl oz Failed Content Uniformity Specifications: The Spray Content Uniformity (SCU) requirement for Standard Deviation did not meet the requirement at the 18-month… Class IIIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month… Class IIIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month… Class IIIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Colchicine Tablets, USP 0.6 mg Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Class IIIFDA’s classMar 22, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedMar 22, 2023ClassClass IIIStatusTerminatedWhereArizona, Mississippi and Ohio
- Medicine recall Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%,… Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity. Class IIFDA’s classMar 22, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 22, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Brimonidine Tartrate Ophthalmic Solution 0.15% Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Heparin Sodium, 25,000USP units per 250 mL Subpotent Drug: low Anti-Factor IIa potency. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials Labeling: Not elsewhere classified Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg Failed Dissolution Specification: Out of specification dissolution results at time point zero. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall NaturalCare bioAllers, Allergy Nasal Spray, Homeopathic, All Region Formula, 0.8 fl oz( 24mL), Mfd CGMP Deviations: Raw material recalled by repackager, due to discoloration. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd CGMP Deviations: Raw material recalled by repackager, due to discoloration. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd CGMP Deviations: Raw material recalled by repackager, due to discoloration. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall NaturalCare, children’s, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ(… CGMP Deviations: Raw material recalled by repackager, due to discoloration. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit. Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Phenylephrine HCl 0.5 mg per 5 mL CGMP DEVIATIONS Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereNationwide, and Virginia named
- Medicine recall Phenylephrine HCl 1mg per 10mL CGMP DEVIATIONS Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereNationwide, and Virginia named
- Medicine recall Phenylephrine HCl 40 mg CGMP DEVIATIONS Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereNationwide, and Virginia named
- Medicine recall Phenylephrine HCl 20 mg CGMP DEVIATIONS Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereNationwide, and Virginia named
- Medicine recall Alcolado Relampago (menthol 1%, camphor 1.5%) CGMP DEVIATIONS Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. CGMP DEVIATIONS Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) CGMP DEVIATIONS Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) CGMP DEVIATIONS Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nose Better Gel CGMP DEVIATIONS Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl CGMP DEVIATIONS Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic… CGMP DEVIATIONS Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall DIBUCAINE 1% HEMORRHOIDAL OINTMENT, 1 oz. Labeling: Incorrect or Missing Lot and/or Exp Date Class IIIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Purely Soothing 15% MSM Drops Non-Sterility FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IStatusOngoingWhereNationwide
- Medicine recall Purely Soothing MSM Nasal Spray, 15% CGMP Deviations Class IIFDA’s classMar 15, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 15, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. Class IIIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2023ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. Class IIIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2023ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity. Class IIIFDA’s classMar 8, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 8, 2023ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
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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