Medicines, 2025
Shortlist up to four to read them side by side.
765 medicine recalls FDA’s Enforcement Report published in 2025, 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.
765of 765 medicine recallsshown with your filters
The list
- Medicine recall Gabapentin Capsules, USP, 100 mg, 100 Capsules Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Gabapentin Capsules, USP, 100 mg, 10 Capsules Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity . Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Cetirizine Hydrochloride Tablets USP 10 mg, 100 Tablets bottles Tablet/Capsules Imprinted with Wrong ID Class IIIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Cetirizine Hydrochloride Tablets USP 10 mg, 500 Tablets bottles Tablet/Capsules Imprinted with Wrong ID Class IIIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL Failed Impurities/Degradation Specifications: The result for ‘Any individual unspecified impurity’ exceeds the specification limit. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Medline, Alcohol Prep Pads Subpotent Drug Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ketorolac Tromethamine Injection, USP, 60 mg/2 mL Presence of Particulate Matter: Particulate matter identified as glass Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles Failed Tablet/Capsule Specifications Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall ZICAM” MEDICATED FRUIT DROPS ELDERBERRY FLAVOR, 25-drops per bottle Labeling: Label Mix-up: The product in the bottle contains elderberry and the label failed to indicate the inclusion of elderberry as an ingredient. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Niacin Extended-release Tablets, USP, 1,000 mg Failed Dissolution Specifications Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL Lack of Assurance of Sterility. Class IIFDA’s classOct 29, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Technology., Ltd., Address: he nan… Marketed Without an Approved NDA/ANDA Class IIFDA’s classOct 29, 2025in FDA’s Enforcement Report2 statesnamed in where it went PublishedOct 29, 2025ClassClass IIStatusOngoingWhereVirginia and Wyoming
- Medicine recall Oxytocin 30 Units/500 mL Subpotent Drug: Testing revealed there was no oxytocin in the IV bag. FDA Class I, its most serious class Class IFDA’s class (needs attention)Oct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IStatusOngoingWhereNationwide
- Medicine recall Tavaborole Topical solution 5%, 10 mL bottle Discoloration Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atorvastatin Calcium Tablets USP, 10 mg Failed Dissolution Specifications Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atorvastatin Calcium Tablets USP, 40 mg Failed Dissolution Specifications Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atorvastatin Calcium Tablets USP, 20 mg Failed Dissolution Specifications Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Atorvastatin Calcium Tablets USP, 80 mg Failed Dissolution Specifications Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01… Failed Impurities/Degradation Specifications Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Aloe Up Sport Performance Sunscreen Lotion SPF 30, 1 FL OZ cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Hydromorphone HCL PF, 10mg/50 mL Labeling: Incorrect or Missing Lot and/or Exp Date Class IIIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Ketamine Hydrochloride, 50mg/5 mL Labeling: Incorrect or Missing Lot and/or Exp Date Class IIIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall FentaNYL Citrate PF, 500mcg/50 mL Labeling: Incorrect or Missing Lot and/or Exp Date Class IIIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips with 7 tablets each) Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. Class IIIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIIStatusOngoingWhereNationwide
- Medicine recall Sucralfate Tablets, USP 1 gram, 100 Tablets CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Fasenra (benralizumab) Injection, 30 mg/mL, one single-dose pre-filled syringe Lack of Assurance of Sterility: Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg)… Class IIFDA’s classOct 22, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 22, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Bevacizumab 1.75 mg/0.07 mL - 0.25 mL syringe, Intravitreal, 0.07 mL Total Volume Lack of assurance of sterility. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl Alcohol 60.1%, Manufacture By:… cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was… Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515) cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol components used to manufacture the listed hand sanitizers was… Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Levothyroxine Sodium Tablets, USP, 88 mcg Subpotent: During long term stability testing of Levothyroxine Sodium Tablets USP for 88 mcg, the assay content was observed below the approved specification… Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3… Failed Content Uniformity Specifications Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Succinylcholine Chloride Injection, USP, 200 mg/10 mL Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications. Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Alpha Lipoic Acid for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204… Lack of Assurance of Sterility Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Amino Blend for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca… Lack of Assurance of Sterility Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ascorbic Acid (Vitamin C) for Injection, Preservative Free, all strengths and presentations, GenoGenix, LLC,… Lack of Assurance of Sterility Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Ascorbic Acid (Vitamin C) for Injection, Preserved, all strengths and presentations, GenoGenix, LLC, 2840 NW… Lack of Assurance of Sterility Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204… Lack of Assurance of Sterility Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall B12 Methylcobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204… Lack of Assurance of Sterility Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall B5 Dexpanthenol for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca… Lack of Assurance of Sterility Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall B6 (Pyridoxine HCl) for Injections, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204… Lack of Assurance of Sterility Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
- Medicine recall Bacteriostatic Water for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204… Lack of Assurance of Sterility Class IIFDA’s classOct 15, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 15, 2025ClassClass IIStatusOngoingWhereNationwide
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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