Browse Drug Recalls

7 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 7 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 7 FDA drug recalls.

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DateProductReasonClassFirm
Jan 7, 2025 Guaifenesin and Codeine Phosphate Oral Solution USP, 100mg/10 mg per 5 mL, 16... Superpotent; sodium benzoate preservative Class III PAI Holdings, LLC. dba Pharmaceutical Associate...
Jul 29, 2021 Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor,... Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. Class II PAI Holdings, LLC. dba Pharmaceutical Associate...
Jul 29, 2021 Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY... Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. Class II PAI Holdings, LLC. dba Pharmaceutical Associate...
Jul 29, 2021 Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Phar... Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup. Class II PAI Holdings, LLC. dba Pharmaceutical Associate...
Sep 9, 2020 Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg... Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9... Class III PAI Holdings, LLC. dba Pharmaceutical Associate...
Aug 4, 2020 Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor,... Subpotent drug: Out of specification for assay at the 15-month test interval. Class II PAI Holdings, LLC. dba Pharmaceutical Associate...
Mar 19, 2020 Nystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor... SubPotent Drug: Low out-of-specification results for assay testing. Class II PAI Holdings, LLC. dba Pharmaceutical Associate...

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.