Browse Drug Recalls
8 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 8 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 8 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 1, 2019 | Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distribute... | Subpotent Drug | Class III | Sato Pharmaceutical Inc. |
| Oct 1, 2019 | WAL-DRAM 2 (meclizine Hydrochloride) 25 mg tablets, packaged in a) 12 count (... | Subpotent Drug | Class III | Sato Pharmaceutical Inc. |
| Oct 1, 2019 | Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, D... | Subpotent Drug | Class III | Sato Pharmaceutical Inc. |
| Oct 1, 2019 | Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) ... | Subpotent Drug: Formulated amount of sennosides component is less than labelled claim. | Class III | Sato Pharmaceutical Inc. |
| Oct 1, 2019 | Motion Sickness (meclizine hydrochloride) 25 mg tablets, 12-count box, Distri... | Subpotent Drug | Class III | Sato Pharmaceutical Inc. |
| Feb 16, 2017 | SATO CLEAR (naphazoline hydrochloride) Redness Reliever Eye Drops, packaged i... | Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring enviro... | Class II | Sato Pharmaceutical Inc. |
| Feb 16, 2017 | DORAMA-NEO (naphazoline hydrochloride) Eye wash, packaged in 0.5 FL OZ (15mL)... | Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring enviro... | Class II | Sato Pharmaceutical Inc. |
| Feb 16, 2017 | Optic Splash (naphazoline hydrochloride) Eye Drops, packaged in 0.5 FL OZ (15... | Lack of Assurance of Sterility: Firm failed to establish an adequate system for monitoring enviro... | Class II | Sato Pharmaceutical 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.