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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.