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, 1000 mL Lack of Assurance of Sterility Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 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 PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 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 PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 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 T Shampoo For Hair and Body, Solution Coal Tar 3% Subpotent Class IIIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 30, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl Subpotent Class IIIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 30, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall screamin’ hot (capsaicin) Pain Relieving Gel, 0.03% CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall screamin’ menthol (menthol) Pain Relieving Gel, 4% CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release. Class IIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 30, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Lidocaine Patch 5% Failed Stability Specifications Class IIIFDA’s classMay 30, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 30, 2018ClassClass IIIStatusTerminatedWhereNo state named
- Medicine recall Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Calendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient… Class IIIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Clindamycin 150 mg capsules, USP, 30-count M-Pak container Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Chlorhexidine 0.12% liquid, 473 MILLITERS Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Clindamycin 300 mg capsules, USP, 28-count M-Pak containers Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer… Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportCaliforniathe one state its words name PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereCalifornia
- Medicine recall Ferrous Sulfate 325 MG tablet Presence of Foreign Tablets/Capsules Class IIIFDA’s classMay 23, 2018in FDA’s Enforcement ReportFloridathe one state its words name PublishedMay 23, 2018ClassClass IIIStatusTerminatedWhereFlorida
- Medicine recall B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East… Microbial Contamination of Non-sterile Product Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 23, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL GMP Deviations Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 23, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma,… GMP Deviations Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 23, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz GMP Deviations Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportPuerto Ricothe one state its words name PublishedMay 23, 2018ClassClass IIStatusTerminatedWherePuerto Rico
- Medicine recall Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg Failed Stability Specifications Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84) Defective delivery system Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Hydrocortisone Ointment, USP 2.5% Failed Stability Specifications Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNationwide, and Puerto Rico named
- Medicine recall Riomet (metformin hydrochloride oral solution), 500 mg/5 mL Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature. Class IIIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IIIStatusTerminatedWhereNationwide
- Medicine recall Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc.,… cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc.,… cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure Class IIFDA’s classMay 23, 2018in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 23, 2018ClassClass IIStatusTerminatedWhereNo state named
- Medicine recall Piperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency FDA Class I, its most serious class Class IFDA’s class (needs attention)May 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Piperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency FDA Class I, its most serious class Class IFDA’s class (needs attention)May 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose… Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass FDA Class I, its most serious class Class IFDA’s class (needs attention)May 23, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 23, 2018ClassClass IStatusTerminatedWhereNationwide
- Medicine recall Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottle Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was found in a 100 count bottle of Metoprolol Succiante… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vitalab Pharmacy, Inc Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, sterile injectable, Vitalab Pharmacy,… Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile injectable, Vitalab Pharmacy, Inc Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable, ST3:Papaverine… Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phentolamine 1mg/Prostaglandin… Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be… Class IIFDA’s classMay 16, 2018in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereNationwide
- Medicine recall Humira Pen Sub-q Kit a.) 40 mg/0.8 mL (NDC 00074-4339-02) Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Albuterol 0.083% Inh Sol. 30 days supply Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Kalydeco 150 mg tablet blister, 28 days supply Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Pediasure Liq Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Polyethylene Glycol 3350, powder, for solution 527g BRE Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Pulmicort Respules 0.5 mg/2mL s, 30 days supply Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Otezla 30 mg tablet Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Taltz 80 mg/mL Pen 1-pk Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
- Medicine recall Cosentyx 150 mg/mL PFS 300 mg Dose Lack of Processing Controls. Class IIFDA’s classMay 16, 2018in FDA’s Enforcement Report5 statesnamed in where it went PublishedMay 16, 2018ClassClass IIStatusTerminatedWhereArkansas, Florida, Illinois, Louisiana and Mississippi
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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