Any time I see the word “recall” in bold lettering at the front of a cautionary headline, I’m immediately intrigued. Even if the product in question isn’t even something I own, give me two seconds and I can guarantee I’ll be skimming the entire copy for the who-done-wrong details. As of late, I’ve come to associate these sorts of recalls with food and the risk of salmonella, but the latest recall has to do with feminine care, specifically birth control — but seriously, don’t panic. Ortho-Novum birth control recalled three different packs on Tuesday, Nov. 6, not because its product was faulty, but because the information scribbled on those cute, mini instruction manuals each pack comes equipped with was apparently incorrect. Elite Daily has reached out to Janssen Pharmaceuticals, Inc. (the makers of Ortho-Novum birth control) for comment on the recall, but did not hear back by time of publication.
UPDATE: Janssen Pharmaceuticals, Inc. sent the following statement to Elite Daily over email:
At Janssen, we believe our first responsibility is to the individuals who use our products and everything we do must be of high quality.
We became aware that the patient information provided inside packages of one lot of ORTHO-NOVUM® 1/35 and two lots of ORTHO-NOVUM® 7/7/7 did not include the appropriate instructions for the Veridate® dispenser. We initiated a voluntary recall at the pharmacy level of affected units.
The ORTHO-NOVUM® product itself remains safe and effective for use with the appropriate dispenser instructions. Women should continue to take the 21 “active” pills for three weeks, followed by the one week of green “reminder” pills.
Consumers with ORTHO-NOVUM® product from the affected lots can access the correct instructions for the Veridate® dispenser pack at https://www.janssen.com/us/our-products and talk to their prescribing medical professional if they have any concerns. Consumers should not stop taking the product and if they do miss a dose, they should follow the instructions included in the packet.
EARLIER: Obviously if you’re popping Ortho-Novum every day, I’m going to go out on a limb here and guess that this isn’t exactly the greatest news you’re going to hear today. At least you can rest assured the actual medication hasn’t been tampered with, though, right?
On Nov. 6, the U.S. Food and Drug Administration (FDA) published a statement issued by Janssen Pharmaceuticals, Inc., which stated from the very first line of text that the birth control product itself “remains safe and effective for use” — that is, with the appropriate instructions.
Per the FDA’s announcement, three lots of Ortho-Novum birth control have officially been recalled: one lot of Ortho-Novum 1/35, and two lots of Ortho-Novum 7/7/7 tablets. The recall was voluntary, according to the FDA, so the good news is, if you use Ortho-Novum, clearly this is a brand you can trust, and a brand that looks out for its customers. And again, this particular recall isn’t one of those hot-in-the-face, oh my goodness I literally just ate that very same piece of lettuce they’re talking about so I’m going to be sick type of scenarios. According to the FDA's announcement, the issue isn’t with the product itself, but rather, the instructions that break down the proper way to take the birth control. The announcement explained,
The patient information provided inside affected packages of ORTHO-NOVUM® does not include the appropriate instructions for the Veridate® dispenser.
The potential risk of taking ORTHO-NOVUM® without the appropriate instructions for correct use of the Veridate® dispenser pack is that the consumer could take the pills in the incorrect order (still receiving an effective dose) or could take an inactive "reminder" pill instead of an "active" pill which could lead to breakthrough bleeding or an unintended pregnancy.
It’s really important that a pack of birth control pills comes with an accurate step-by-step set of instructions, especially for those who are new to this particular form of contraception, or the actual brand of medication. For those who don’t know, in a cycle’s worth of oral contraception, there are two types of pills: active pills and inactive pills. According to the Mayo Clinic, the standard birth control pack will contain 28 pills, 21 of which are active. This means that of the 28 pills you’re scheduled to take throughout your cycle, only 21 of them contain the hormones needed to suppress ovulation, and therefore prevent an unwanted pregnancy. The remaining seven pills are referred to as inactive pills, meaning they’re more or less placebos taken to encourage a breakthrough bleed.
I know myself, and when I was on birth control, the brand I used made it obvious which pills were which by making each set a different color. But some packs can be confusing, and regardless of how long you’ve been using your medication, it’s always a good idea to review the instructions that come along with your birth control, in order to make sure you're following the right steps to prevent an unwanted pregnancy. In this case, according to the FDA's announcement, the Ortho-Novum manuals apparently failed to provide its customers with the correct timeline of pills, which means, if you take an inactive pill when you’re really supposed to pop an active tablet, there’s a chance you could become pregnant if you have sex that day and do not use any additional form of protection, like a condom.
The good news is, if you already have a packet of any one of the three lots of birth control that Ortho-Novum recalled, you don’t necessarily have to trudge all the way to the pharmacy, or make an appointment with your gynecologist to demand a new box. You can still take the pills; according to the company's statement, you just have to know how to take them and which pills to take on the correct day:
Women should continue to take the 21 "active" pills (with hormones) (peach for ORTHO-NOVUM® 1/35; white, light-peach and peach for ORTHO-NOVUM® 7/7/7) for three weeks, followed by the one week of green "reminder" pills (without hormones).
To be absolutely sure you're taking the right pills, you can access the correct instructions by logging on to https://www.janssen.com/us/our-products. However, if you have any additional questions or concerns, don’t hesitate to call or make an appointment with your doctor to address them.