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

• 6drug recalls (since 1 Jan 2023)
• 2device recalls (since 1 Jan 2023)
• 47,162side effect reports (reports received since 1 Jan 2023)

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

• 27May2026

  Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg, 0.75mg/0.035mg, 1 mg/0.0.35mg, 3 Blister Cards each containing 28 tablets, 28 da…

  Reason: Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specification results total impurities.

  D-0588-2026
• 3Sep2025

  Viorele, Desogestrel and Ethinyl Estradiol, USP, 0.15 mg/ 0.02 mg and Ethinyl Estradiol Tablets, USP, 0.01 mg, 3 Blisters each containing 28 Tablets, Rx only,…

  Reason: Failed Impurities/Degradation Specifications

  D-0021-2026
• 2Sep2025

  Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx…

  Reason: Failed Content Uniformity Specifications

  D-0007-2026
• 7Mar2024

  Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister Cards, 28 Tablets Each, Rx only,…

  Reason: Failed Dissolution Specifications

  D-0428-2024
• 25Jan2024

  Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx…

  Reason: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

  D-0321-2024
• 25Jan2024

  Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contai…

  Reason: Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

  D-0322-2024

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

• 21May2026

  Tray, Surgical

  Reason: The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to quality issues identi…

  Z-2542-2026
• 3Dec2024

  Remover, Intrauterine Device, Contraceptive, Hook-Type

  Reason: Reports of various packaging issues that may result in a breach of the sterile barrier.

  Z-0948-2025

Source: openFDA, Medical device recalls, since 1 Jan 2023. Retrieved 12 Nov 2026.

1. 1Meningioma12,071 reports
2. 2Foreign body in reproductive tract2,862 reports
3. 3Embedded device2,276 reports
4. 4Heavy menstrual bleeding2,082 reports
5. 5Vaginal haemorrhage1,792 reports
6. 6Procedural pain1,720 reports
7. 7Pain1,689 reports
8. 8Pelvic pain1,568 reports
9. 9Emotional distress1,515 reports
10. 10Anxiety1,367 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.

• Contraception use

• Women's health
• Maternal