Medicines, 2020
Shortlist up to four to read them side by side.
1,035 medicine recalls FDA’s Enforcement Report published in 2020, 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.
1,035of 1,035 medicine recallsshown with your filters
The list
- Medicine recall Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton Labeling Not Elsewhere Classified: The statement Pharmacist: Dispense with the accompanying Medication Guide was not included on the carton label. Class IIIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 90 count bottle CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJul 1, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, 100 count bottles CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above acceptable intake levels Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusCompletedWhereNationwide
- Medicine recall Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC… CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (NDC 50268-531-15) CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall metFORMIN HCL ER USP 500 mg, a) 30 tablets (NDC: 43063-428-30) CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall EcoLips Sport Lip Balm, SPF 30, Avobenzone Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allowable 3% in the sunscreen formula per FDA sunscreen regulations. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Heparin Sodium 5,000 units Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement Report2 statesnamed in where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereCalifornia and Pennsylvania
- Medicine recall Olanzapine Tablets, USP 2.5 mg, 30-count bottle Failed Impurities/ Degradation Specifications Class IIIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Olanzapine Tablets, USP 7.5 mg, 30-count bottle Failed Impurities/ Degradation Specifications Class IIIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Gaviscon Regular Strength Liquid Antacid Cool Mint, 6 FL OZ Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gaviscon Extra Strength Liquid Antacid Extra Strength Cherry, 12 FL OZ. Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gaviscon Liquid Antacid Extra Strength, Cool Mint, 12 FL OZ Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label. Class IIFDA’s classJun 24, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lisinopril Tablets, USP, 5 mg Product Mix Up: Lisinopril 10 mg tablets were found in Lisinopril 5 mg 1000-count bottle. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Clonidine Hydrochloride Tablets, USP 0.1 mg 100-count bottles Failed Impurities/Degradation Specifications: potential migration of benzophenone at very low level into the product from container. Class IIIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton Failed dissolution specification - dissolution results of 59% (spec. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ketorolac Tromethamine Injection, USP, 30 mg per mL Presence of Particulate Matter - found in reserve sample vials at the firm. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 17, 2020ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL Presence of Particulate Matter - found in reserve sample vials at the firm. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall oxyTOCIN 30 Units/500 mL Subpotent drug - Product did not contain drug. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Unasyn (ampicillin sodium/sulbacatam) for injection, 1.5 g* per vial Presence of Particulate Matter: particulate matter identified after reconstitution. Class IIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle Discoloration: Out of Specification (OOS) result for APHA Color Test. Class IIIFDA’s classJun 17, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 17, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Estriol USP Micronized 5 G Failed impurities/ degradation specifications: Out of specification for organic impurities. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate… Some bottles may contain mixed strengths of the product. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate… Some bottles may contain mixed strengths of the product. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate… Some bottles may contain mixed strengths of the product. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Doxycycline Hyclate Tablets, USP, 100 mg Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result. Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lamotrigine Tablets, USP, 150 mg Presence of Foreign Substance consistent with granules from desiccant packs used during storage Class IIIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 10, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain Superpotent Drug. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall NP Thyroid 60, Thyroid Tablets, USP, 1 grain Superpotent Drug. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain Superpotent Drug. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Carbamazepine Tablets, USP 200 mg Failed Dissolution Specifications Class IIFDA’s classJun 10, 2020in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 10, 2020ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Doxycycline Hyclate Tablets USP, 100 mg Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result. Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Doxycycline Hyclate tablets USP, 100 mg Failed dissolution specifications Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 patches per box CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within… Class IIFDA’s classJun 3, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 3, 2020ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Lamotrigine Tablets, USP, 150 mg, 20,000-count bulk container Presence of Foreign Substance visually consistent with the silica granules present in the desiccant packs utilized during storage of the product. Class IIIFDA’s classJun 3, 2020in FDA’s Enforcement ReportTennesseethe one state its words name PublishedJun 3, 2020ClassClass IIIStatusTerminatedWhereTennessee
- Medicine recall LACTATED RINGER’S Injection, USP 1000 mL flexible container Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2020ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and… Class IIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2020ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gabapentin Tablets USP, 600 mg Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing. Class IIIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants. Class IIIFDA’s classMay 27, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 27, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing. Class IIIFDA’s classMay 20, 2020in FDA’s Enforcement Report6 statesnamed in where it went PublishedMay 20, 2020ClassClass IIIStatusTerminatedWhereAlabama, Florida, Iowa, New York, Ohio and Texas
- Medicine recall ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card Class IIIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card Class IIIFDA’s classMay 20, 2020in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 20, 2020ClassClass 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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