Sandoz Recalls Introvale Contraceptive Tablets Due to Sequence Error
Sandoz is voluntarily recalling Introvale contraceptive tablets because inactive and active pills were placed in the wrong weeks on the blister card.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The hazard is a packaging/sequencing error rather than a contamination or structural defect, fitting the criteria for a moderate severity score.
Plain-English summary
Sandoz Incorporated is voluntarily recalling Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg. The recall involves 8,681 unit cartons distributed nationwide. The specific lots affected are LF01643C and LF01644C, with an expiration date of 7/14.
The recall was initiated because inactive placebo tablets were incorrectly placed in Week 9, and active tablets were placed in Week 13 on the blister card. This sequencing error means the medication schedule on the packaging does not match the actual contents of the blister card.
Consumers with this product should stop using it and contact their healthcare provider or pharmacist for guidance. The product is prescription-only and was manufactured by Laboratorios Leon Farma S.A. in Spain for Sandoz Inc.
The recalled product
- Product
- Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36
- Manufacturer
- Sandoz Incorporated
- Category
- Drug — Contraceptive
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lots: LF01643C
- LF01644C
- Exp 7/14
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Sandoz Incorporated
See all →- ModerateSandoz Recalls Triamterene and Hydrochlorothiazide Tablets Due to Cross-Contamination
FDA (Drugs) · 2018-04-25
- ModerateSandoz Recalls Amitriptyline Hydrochloride Tablets Due to Cross-Contamination
FDA (Drugs) · 2017-07-12
- ModerateSandoz Recalls Nadolol Tablets Due to Failed Dissolution Test
FDA (Drugs) · 2017-01-04
- LowSandoz Recalls Fluoxetine Capsules Due to Illegible Logo
FDA (Drugs) · 2014-12-17
- SevereSandoz Recalls Alprazolam Tablets Due to Stainless Steel Particulates
FDA (Drugs) · 2014-08-06
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- ModerateHalyard Laparoscopy Comprehensive Pack II Recalled for Latex Content
FDA (Devices) · 2026-10-14
Similar recalls
- SevereSandoz Recalls Estarylla Contraceptive Tablets Due to Placebo Tablet Error
FDA (Drugs) · 2013-07-24
- LowSandoz Recalls Syeda Oral Contraceptives for Incorrect Tablet Imprinting
FDA (Drugs) · 2013-02-13
- LowSandoz Recalls Lisinopril Tablets Due to Missing Package Insert
FDA (Drugs) · 2016-06-22
- ModerateApotex Recalls Out-of-Sequence Contraceptive Tablets
FDA (Drugs) · 2019-03-13
- ModerateTeva Recalls Amethyst Oral Contraceptive Tablets Due to Incorrect Labeling
FDA (Drugs) · 2017-12-27
- SevereSandoz Recalls Cefazolin Injection Vials Due to Sterility Concerns
FDA (Drugs) · 2013-06-19