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Browse Drug Recalls

37 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 37 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 37 FDA drug recalls.

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DateProductReasonClassFirm
Oct 26, 2023 Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, M... Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution wi... Class III VistaPharm LLC
Oct 18, 2023 Sucralfate Oral Suspension, 1g per 10mL, 16 oz (414 mL) PET bottle (12 bottle... Microbial Contamination of Non-Sterile Products: identified as Bacillus cereus. Class I VistaPharm LLC
Oct 17, 2023 Aminocaproic Acid Oral Solution, 0.25 grams/mL, Rx only, packaged in 8 Fl. Oz... Failed Excipient Specifications: high content of ethylene glycol (EG) Class III VistaPharm LLC
Aug 30, 2023 Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL ... Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results Class II VistaPharm LLC
Sep 30, 2022 Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged ... cGMP Deviations: Out of specification for assay of one of the preservative ingredients. Class II VistaPharm, Inc.
Jan 7, 2022 Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by... Failed Stability Specifications Class II VistaPharm, Inc.
Sep 25, 2020 NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v... Failed Impurties/Degradation Specifications: out of specification results for an impurity for one... Class III VistaPharm, Inc.
Jun 23, 2020 Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl... Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved sp... Class III VistaPharm, Inc.
Jun 23, 2020 Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only,... Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved sp... Class III VistaPharm, Inc.
Nov 30, 2018 NYSTATIN Oral Suspension, USP 500,000 Units/5mL, unit dose 5ml cups, packaged... Failed Impurities/Degradation Specifications:Out of specification for impurities. Class III VistaPharm, Inc.
Aug 17, 2017 Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 m... Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substa... Class III VistaPharm, Inc.
Jun 26, 2017 Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-uni... Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. Class II VistaPharm, Inc.
Jun 26, 2017 Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-... Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. Class II VistaPharm, Inc.
May 17, 2017 Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60m... Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved ... Class III VistaPharm, Inc.
Jan 18, 2017 Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 ... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (3... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 l... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL, a). 5 mL, 50 unit dose ... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL, packaged in 15... Defective Container: Leakage of unit dose cups that may occur at the seal. Class II VistaPharm, Inc.
Jan 18, 2017 Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per ca... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottl... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Nystatin Oral Suspension, USP 500,000 Units/5 mL, a). 50 unit dose cups of 5 ... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx o... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx o... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Jan 18, 2017 Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL pe... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, Inc.
Nov 9, 2016 Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01),... Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence o... Class II VistaPharm, Inc.
Apr 18, 2016 Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) (NDC 66689-401-... Defective Container: Excess lidding material accumulation between the seal and the cup resulting ... Class II VistaPharm, Inc.
Jun 26, 2015 METOCLOPRAMIDE ORAL SOLUTION, USP 10 mg/10 mL, 10 mL cups, Rx only. Manufactu... Defective Container: Lids on unit dose cups are not fully qualified. Class III VistaPharm, Inc.
Aug 13, 2014 METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, (present as the hydrochloride), ... Defective Container: Product leaks when inverted. Class II VistaPharm, Inc.
Oct 15, 2013 Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administ... Defective Container: A lidding deformity allowed for the product to have out of specification res... Class II VistaPharm, Inc.
Jul 4, 2013 Nystatin Oral Suspension, USP 500,000 units/ 5 mL (NDC 66689-037-01 ) Rx Onl... Failed Impurites/Degradation Specifications: Test failure of single largest peak at 18 months. Class II VistaPharm, Inc.
May 15, 2013 Ranitidine Syrup (Ranitidine Oral Solution USP) 15 mg/mL, Rx Only. Manufactu... Failed Impurity/Degradation Specification; "Related Compound C" Class II Actavis South Atlantic LLC
May 30, 2012 Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL,... Impurities/Degradation Products: exceeded specification at 3 month stability testing Class II VistaPharm, Inc.
Sep 30, 2011 Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dos... Defective container; lidding deformity allows the contained product to transpire causing potentia... Class II VistaPharm, Inc.
Apr 6, 2011 Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit d... Defective container; lidding deformity allows the contained product to transpire causing potentia... Class II VistaPharm, Inc.
Jan 19, 2011 METOCLOPRAMIDE ORAL SOLUTION, USP 5 mg/5 mL, This cup delivers 10 mL, Rx Only... Labeling: Correct Labeled Product Miscart/Mispack: The shipper label displayed "5 mL x 50," inste... Class III VistaPharm, Inc.

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.