Browse Drug Recalls

448 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 448 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 448 FDA drug recalls in MI.

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DateProductReasonClassFirm
Feb 9, 2018 Duloxetine HCl USP for prescription compounding, packaged in a)100g (NDC 5859... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Estradiol USP (Micronized) (Yam) for prescription compounding, packaged in a)... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Tadalafil USP (Monohydrate) for prescription compounding, packaged in a) 5g ... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Cyclobenzaprine HCl USP for prescription compounding, packaged in a) 25g (NDC... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Baclofen USP (Micronized) for prescription compounding, packaged in a) 25g (N... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Testosterone Cypionate USP (Micronized) for prescription compounding, packag... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Calcipotriene BP (Monohydrate) for prescription compounding, packaged in a) 2... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Nifedipine USP for prescription compounding, packaged in a) 5g (NDC 58597-80... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Nov 8, 2017 Maximum Strength Zephrex-D, Pseudoephedrine HCl, 30 mg, Nasal Decongestant. ... Microbial Contamination of Non-Sterile Products Class II L. Perrigo Company
Sep 26, 2017 Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx ... Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity. Class II The Harvard Drug Group
Aug 2, 2017 Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl o... Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... Class II The Harvard Drug Group
Aug 2, 2017 Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (23... Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... Class II The Harvard Drug Group
Aug 2, 2017 Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120... Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... Class II The Harvard Drug Group
Aug 2, 2017 Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, On... Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... Class II The Harvard Drug Group
Aug 2, 2017 Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One... Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... Class II The Harvard Drug Group
Jun 5, 2017 Walgreens Daytime and Nighttime Cold & Flu, packaged in combo pack of two pla... Labeling: Label Mix-Up - This product is being recalled due to an incorrect product sleeve on the... Class III L. Perrigo Company
Jun 1, 2017 Doxycycline Hyclate USP, active pharmaceutical ingredient, a) 25 g packaged ... Labeling: Not Elsewhere Classified. Manufacturer and product were discovered to be on FDA Import ... Class II American Pharmaceutical Ingredients LLC
Jun 1, 2017 Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive, 1 Tablet pe... Defective Container: Carton is missing the tablet blister strip and tablet. Class II L. Perrigo Company
May 26, 2017 Methocarbamol, USP, packaged in a) 100 g container (NDC: 58597-8023-6, b) 500... CGMP Deviations: Lack of quality assurance at the API manufacturer. Class II American Pharmaceutical Ingredients LLC
Apr 28, 2017 Buprenorphine HCI Injection, 0.3 mg/mL, 1 mL Single Dose Vial (NDC 42023-179-... Crystallization: due to the presence of white, crystalline particulates, adhered to the side and ... Class II PAR Sterile Products LLC
Apr 17, 2017 ESTRONE USP, packaged in a) 1g bottle (NDC: 58597-8049-2), c) 5g bottle (NDC:... cGMP Deviations; lack of quality assurance. Class II American Pharmaceutical Ingredients LLC
Feb 13, 2017 Salicylic Acid Shampoo, 6%, 177 mL bottle, Rx only, Manufactured By Perrigo Y... Failed Impurities/Degradation Specifications: The API for these products had an out of specificat... Class III L. Perrigo Company
Feb 13, 2017 Salicylic Acid Cream, 6%, 400g bottle, Rx Only, Manufactured By Perrigo Yeruh... Failed Impurities/Degradation Specifications: The API for these products had an out of specificat... Class III L. Perrigo Company
Jan 5, 2017 Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufa... Failed Dissolution Specifications Class II The Harvard Drug Group
Jan 5, 2017 Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufa... Failed Dissolution Specifications Class II The Harvard Drug Group
Dec 28, 2016 Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/5%, 45 g tubes, Rx Only,... Microbial Contamination of Non-Sterile Product; small number of tubes may include the presence of... Class II L. Perrigo Company
Dec 27, 2016 Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by ... Superpotent Drug; out of specification results for assay (manufacturer) Class III The Harvard Drug Group
Jul 15, 2016 Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint ... Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia Class I The Harvard Drug Group
Jan 27, 2016 Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl ... Marketed without an approved NDA/ANDA Class II Bonita Pharmaceuticals, LLC
Jan 18, 2016 Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perri... Labeling: label error on declared strength. Class II Perrigo Company PLC
Jan 18, 2016 Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrig... Labeling: label error on declared strength. Class II Perrigo Company PLC
Jan 8, 2016 Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged w... Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorre... Class II Perrigo Company PLC
Jan 8, 2016 Guaifenesin DM Cherry liquid (guaifenesin 100 mg/5 mL and Dextromethorphan HB... Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorre... Class II Perrigo Company PLC
Sep 28, 2015 Cetirizine HCl 10 mg Tablet, 14 count blister packs, sold over the counter un... Failed Impurity/Degradations Specifications; impurity identified as cetirizine monosaccharide ester Class III Perrigo Company PLC
Jun 10, 2015 OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manuf... Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 ... Class II The Harvard Drug Group, LLC
Aug 19, 2014 Nicotine Polacrilex Lozenge, 2 mg Mint Mini. 27 Ct Tubes, Over the Counter. ... Failed Dissolution Specifications and Failed Tablet Specifications: High 30 minute dissolution te... Class III Perrigo Holland Inc
Jun 26, 2014 Cephalexin Capsules, USP, 500 mg, packaged in a) 100-count bottles (NDC 62756... CGMP Deviations: These products are being recalled because they were manufactured with active pha... Class II Caraco Pharmaceutical Laboratories, Ltd.
Jun 26, 2014 Cephalexin Capsules, USP, 250 mg, packaged in a) 100-count bottles (NDC 62756... CGMP Deviations: These products are being recalled because they were manufactured with active pha... Class II Caraco Pharmaceutical Laboratories, Ltd.
Jun 12, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, Rx only, Packaged... Failed Dissolution Specifications: Stability results found the product did not meet the drug diss... Class II Caraco Pharmaceutical Laboratories, Ltd.
May 28, 2014 LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Servic... Non Sterility; microbial contamination identified as Aspergillus species Class I Central Admixture Pharmacy Services, Inc.
May 28, 2014 PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services,... Non Sterility; microbial contamination identified as Aspergillus species Class I Central Admixture Pharmacy Services, Inc.
May 28, 2014 adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pha... Non Sterility; microbial contamination identified as Aspergillus species Class I Central Admixture Pharmacy Services, Inc.
May 28, 2014 del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Ph... Non Sterility; microbial contamination identified as Aspergillus species Class I Central Admixture Pharmacy Services, Inc.
Apr 9, 2014 Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, ... Lack of Assurance of Sterility: A particle excursion for a different batch of the same product ma... Class II Caraco Pharmaceutical Laboratories, Ltd.
Apr 9, 2014 Children's Cetirizine Hydrochloride Chewable Tablets, 10 mg, 30 count bottle... Failed Impurities/Degradation Specifications: out of specification results for impurities/degrada... Class III Caraco Pharmaceutical Laboratories, Ltd.
Apr 9, 2014 Cetirizine Hydrochloride Chewable Tablets, 5 mg, 30 count bottle, OTC Manufac... Failed Impurities/Degradation Specifications: out of specification results for impurities/degrada... Class III Caraco Pharmaceutical Laboratories, Ltd.
Mar 20, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 150 mg, packaged in a) 30... Failed Dissolution Specifications: Stability results found the product did not meet the drug rele... Class II Caraco Pharmaceutical Laboratories, Ltd.
Mar 20, 2014 Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 3... Failed Dissolution Specifications: Stability results found the product did not meet the drug rele... Class II Caraco Pharmaceutical Laboratories, Ltd.
Jan 28, 2014 Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx only, 500 count bott... Presence of Foreign Tablet; customer complaint of some tablets of Gabapentin found in a bottle of... Class II Caraco Pharmaceutical Laboratories, Ltd.
Nov 1, 2013 Acetaminophen suspension liquid, 160 mg/5 mL, grape flavor, 2 FL OZ (59 mL) b... Defective Delivery System: There is a remote potential that cartons of product could be co-packag... Class II L. Perrigo Co.

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.