Smoking: FDA Approvals, Recalls, 510(k) Clearances and Side Effect Reports

• 1drug recalls (since 1 Jan 2023)
• 3,439side effect reports (reports received since 1 Jan 2023)

Each number has its full source under its own list below.

• 11Nov2025

  Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56

  Reason: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

  D-0219-2026

Source: openFDA, Drug recall enforcement reports, since 1 Jan 2023. Retrieved 12 Nov 2026.

1. 1Nausea201 reports
2. 2Nicotine dependence170 reports
3. 3Headache139 reports
4. 4Drug dependence138 reports
5. 5Dizziness119 reports
6. 6Vomiting113 reports
7. 7Dyspnoea111 reports
8. 8Fatigue84 reports
9. 9Anxiety79 reports
10. 10Pruritus77 reports

Anyone can send a report. A report does not prove that the medicine caused the reaction, and the counts do not show how often it happens.

Source: openFDA, FDA Adverse Event Reporting System (FAERS), reports by reaction, reports received since 1 Jan 2023. Retrieved 12 Nov 2026.

• Smoking (adults)
• Tobacco use (adults, WHO)

• Respiratory
• Oncology
• Dental