Browse Drug Recalls
11 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 11 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 11 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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... |
| Apr 13, 2022 | Diphenhydramine HCl oral solution, USP, 25 mg/10 mL UD, packaged in a) 10 mL ... | cGMP deviations: Temperature abuse | Class II | Mckesson Medical-Surgical Inc. Corporate Office |
| 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... |
| Jan 14, 2020 | Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, ... | Subpotent: Out of specification for assay at the 12-month time point. | Class II | Pharmaceutical Associates Inc |
| May 29, 2018 | Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Onl... | Resuspension problems: Out of specification for appearance and resuspendability. | Class III | Pharmaceutical Associates Inc |
| Oct 16, 2014 | Cyproheptadine HCl Syrup (Cyproheptadine HCl Oral Solution, USP) 4mg/10 mL, R... | Failed Impurities/Degradation Specifications : Out-of-specification result for an unidentified im... | Class II | Pharmaceutical Associates 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.