Medicines, 2018
Shortlist up to four to read them side by side.
1,426 medicine recalls FDA’s Enforcement Report published in 2018, 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.
1,426of 1,426 medicine recallsshown with your filters
The list
- Medicine recall 0.9% Sodium Chloride Injection, USP, 100 mL bag Lack of assurance of sterility: Bags have potential to leak. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 0.9% Sodium Chloride Injection, USP, 100 mL bag Lack of assurance of sterility: Bags have potential to leak. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall 5% Dextrose Injection, USP, 250 mL bag Lack of assurance of sterility: Bags have potential to leak. Class IIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 27, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle Failed Impurities/Degradation Specifications Class IIIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 27, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle Failed Impurities/Degradation Specifications Class IIIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 27, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Atorvastatin Calcium Tablets, 40 mg* Failed Impurities/Degradation Specifications Class IIIFDA’s classJun 27, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 27, 2018ClassClass IIIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Preferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg,… CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall RPC Senna Syrup (Sennosides 8.8mg) CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall RPC Children’s Non-Aspirin (Acetaminophen 160 mg) Elixir CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall RPC APAP Elixir (Acetaminophen 160mg) CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg) CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Geritrex Senna Syrup (sennosides 8.8mg) CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall SDA Senna Syrup (Sennosides 8.8mg) CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall HYDROmorphone HCl 0.5 mg per mL Superpotent and Subpotent Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall READYFLUSH PROTECT with Dimethicone Microbial Contamination of a Non-Sterile Product. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall X-Jow (menthol USP) Pain Gel, 1.25% CGMP Deviations: products may be contaminated with bacteria. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ CGMP Deviations: products may be contaminated with bacteria. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ CGMP Deviations: products may be contaminated with bacteria. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic acid) Shave Cream Acne Shield, one… CGMP Deviations: products may be contaminated with bacteria. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teething, 1 Fl Ounce glass amber… Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm,… Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nausea Drops, Homeopathic Drops for Temporary Relief of Motion Sickness, Morning Sickness, and General… Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm,… Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Intestinal Colic Drops, Homeopathic Drops for Temporary Relief of Flatulent Colic, 1 ounce amber glass bottle… Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm,… Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, 8 fl Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm,… Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Expectorant Cough Syrup, Homeopathic Syrup for Temporary Relief of Cough & Bronchitis. 8 Fl Ounces amber PET… Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm,… Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl oz Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm,… Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Silver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120ml,amber PET bottle with white… Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm,… Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Monsel’s Solution (Ferric Subsulfate), 20% CGMP Deviations: Products not manufactured under current good manufacturing practices. Class IIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJun 20, 2018ClassClass IIStatusTerminatedWhereNationwide, and Illinois named
- Medicine recall Allergan Taytulla Softgel Capsules, 1 mg/20 mcg, 6x28 blister card Physicians’s Sample - Not for Sale Contraceptive Tablets Out of Sequence. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification. Class IIIFDA’s classJun 20, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 20, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Fluticasone propionate Nasal Spray, USP, 50 mcg Presence of foreign substance: glass particles Class IIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only Resuspension problems: Out of specification for appearance and resuspendability. Class IIIFDA’s classJun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 13, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Valsartan Tablets USP, 320 mg, 90 tablet Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone). Class IIIFDA’s classJun 13, 2018in FDA’s Enforcement Report7 statesnamed in where it went PublishedJun 13, 2018ClassClass IIIStatusTerminatedWhereIndiana, Michigan, Mississippi, North Carolina, New Jersey, New York and Ohio
- Medicine recall Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL Presence of Particulate Matter; Potential for particulate matter on the syringe plunger. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 13, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJun 13, 2018ClassClass IStatusTerminatedWhereNationwide, and Guam and Puerto Rico named
- Medicine recall Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Labeling: Missing Label Class IIIFDA’s classJun 6, 2018in FDA’s Enforcement ReportOhiothe one state its words name PublishedJun 6, 2018ClassClass IIIStatusTerminatedWhereOhio
- Medicine recall POSEIDON Xtreme PLATINUM 4500,1000mg Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall 7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108,… Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 6, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 6, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Rhino 69 Extreme 50000 Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 30, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Loxapine Capsules, USP 25 mg GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Loxapine Capsules, USP 50 mg GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Loxapine Capsules, USP 25 mg CGMP Deviations Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Loxapine Capsules, USP 50 mg CGMP Deviations Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNationwide, 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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