Allergan Recalls Taytulla Contraceptive Softgels Due to Out-of-Sequence Tablets
Allergan is recalling Taytulla softgel capsules because the tablets are out of sequence. This affects 168,768 blister cards distributed nationwide.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states the agency classification is Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must never go below 4. Since no deaths are reported, the score is 4 (Severe).
Plain-English summary
Allergan, PLC. is recalling Taytulla (norethindrone acetate and ethinyl estradiol, and ferrous fumarate) softgel capsules. The recall is due to the contraceptive tablets being out of sequence. The affected product is identified by Lot# 5620706 with an expiration date of 05/19.
The recall involves 168,768 blister cards, which contain a total of 4,725,504 softgel capsules. These products were distributed nationwide in the United States. The specific NDC codes for the affected packaging are 0023-5862-28, 0023-5862-29, and 0023-5862-31.
Consumers and healthcare providers should stop using the affected Taytulla softgel capsules and contact their healthcare provider for guidance. The FDA has classified this recall as Class I, indicating a reasonable probability that use of the product may cause serious adverse health consequences or death.
The recalled product
- Product
- TAYTULLA (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE)
- Brand
- TAYTULLA
- Manufacturer
- Allergan, PLC.
- Category
- Drug — Contraceptive
- Hazard
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 (2)
- Lot# 5620706
- Exp. 05/19
UPCs (1)
- 300235862290
Distribution
Distributed nationwide across the United States.
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