Drug Recall Firms

The recalling firm is the company legally responsible for initiating or conducting a drug recall. This is often the manufacturer, but can also be a distributor, repackager, or the entity whose name appears on the drug label. In cases where a drug is manufactured by a contract manufacturer and sold under a brand owner's label, the recalling firm may be the brand owner rather than the actual factory. The FDA identifies the recalling firm in every enforcement action record.

Yes. Under the FDA Safety and Innovation Act, the FDA has mandatory recall authority for drugs. If a company refuses to voluntarily recall a drug the FDA considers a serious health risk, the FDA can order a mandatory recall. In practice, the vast majority of drug recalls are voluntary, pharmaceutical companies initiate recalls proactively to avoid regulatory action, civil liability, and reputational damage. Mandatory drug recalls are rare but are used when companies contest an FDA safety determination.

Stop taking the medication and contact your pharmacist or doctor immediately. Do not flush medications down the drain, most pharmacies have drug take-back programs. Your pharmacy may have already received notification and can provide a replacement prescription. Check whether the recall applies to your specific lot number and expiration date, as recalls often affect only certain production batches. If you experienced any adverse effects, report them to FDA MedWatch at 1-800-FDA-1088.

Use the search bar above to look up any company by name. You can also use the Browse All Recalls page to filter by keyword, which will search across firm name, product description, and recall reason. For current recall alerts, the FDA publishes new drug recalls on FDA.gov and through the MedWatch email alert system. Pharmacies receive direct notification from manufacturers and wholesalers when a product in their inventory is recalled.