Medicines, 2023
Shortlist up to four to read them side by side.
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 Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0… CGMP Deviations: Use of non-food grade lubricant in mixing vessel. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide
- Medicine recall HYDROmorphone HCl 10 mg CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity… Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportMissourithe one state its words name PublishedJun 7, 2023ClassClass IIStatusOngoingWhereMissouri
- Medicine recall Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement Report3 statesnamed in where it went PublishedJun 7, 2023ClassClass IIStatusTerminatedWhereNorth Carolina, South Carolina and Virginia
- Medicine recall Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride Class IIIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 7, 2023ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Acetaminophen & Codeine Phosphate Oral Solution 120mg/12mg/5mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Acetic Acid Otic Solution, 15 mL per bottle CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Acyclovir Oral Suspension, 200mg/5mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Albuterol Sulfate Syrup, 2mg (base), 16 fl oz CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Apraclonidine Ophthalmic Solution 0.5% CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Artificial Tears Solution, Polyvinyl Alcohol 1.4%, For Ophthalmic Use Only CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Artificial Tears Ointment, Sterile, For Ophthalmic Use Only, 3.5 gram tubes CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Azelastine Hydrochloride Nasal Spray, 0.15%, 105.5 mcg per spray CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall AK-POLY-BAC (bacitracin Zinc and Polymyxin B Sulfate) Ophthalmic Ointment, 3.5g, Sterile CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Calcipotriene Topical Solution, 0.005% (Scalp Solution), 60 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Calcitriol Injection 1 mcg/mL, 1 mL ampules CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Cetrorelix Acetate for Injection, 0.25 mg, , One carton contains one CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Ciclopirox Topical Solution 8% (Nail Lacquer), 6.6 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Cimetidine HCl Oral Solution 300mg/5mL, 237 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Clobetasol Propionate Cream, USP, 0.05% CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Clobetasol Propionate Ointment, USP, 0.05%, 15 g tubes CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Clobetasol Propionate Shampoo, 0.05%, 4oz CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Cromolyn Sodium Ophthalmic Solution, USP, 4%, 10 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall DetomiSed (detomidine hydrochloride) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Dicyclomine Hydrochloride Injection USP, 20 mg/2 mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Diuril (chlorothiazide sodium) Injection, 500mg/vial, Single-Dose Vial CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall DOCU LIQUID (docusate sodium, 50 mg/5 mL) CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Ephedrine Sulfate Injection, USP, 50 mg/mL, 1mL Single Dose Ampules, For Intravenous Use CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Ferrous Sulfate Iron Supplement Drops CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Fluticasone Propionate Nasal Spray, 50mcg, 16 g bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Gonak Hypromellose Ophthalmic Solution 25mg/mL, 15 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Granisetron HCl Injection, USP, 1 mg/mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Guaiatussin AC Sugar-Free, Each teaspoonful CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Guaifenesin Oral Solution, 300 mg/ 15 mL, Sugar Free/Alcohol Free CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall HydrALAZINE HCl Injection, USP, 20 mg/mL, 1 mL Single Dose vials, For Intramuscular or Intravenous Use CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Hydromorphone Hydrochloride Injection, USP, 50mg/5mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall IC-Green (indocyanine green for injection, USP) 25 mg/10 mL Kit CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Ketorolac Tromethamine Ophthalmic Solution, 0.5%, Sterile CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Lactulose Solution, USP (Oral), 10g/15 mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Levetiracetam Oral Solution 100 mg/mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Levocarnitine Oral Solution, USP, 118 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Levofloxacin Injection 500mg/20 mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Levofloxacin Oral Solution, 25 mg/mL CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Levofloxacin Ophthalmic Solution, 0.5%, 5 mL bottles CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Lidocaine 2.5% & Prilocaine 2.5% Cream, 30 gram tubes CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medicine recall Lidocaine Ointment USP, 5%, 1 1/4 oz tubes CGMP Deviations: Firm went out of business and could no longer continue stability studies. Class IIFDA’s classJun 7, 2023in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 7, 2023ClassClass IIStatusOngoingWhereNationwide, 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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