The Recall Desk
ModerateFDA (Drugs)·D-0638-2020·Announced 2020-01-15

Lupin Recalls Blisovi Fe 1.5/30 Tablets Due to Crumbling

Lupin Pharmaceuticals is recalling Blisovi Fe 1.5/30 tablets because they crumble when removed from the blister pack.

What this means for you

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 II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The specific defect is physical crumbling, which is a quality issue rather than a contamination or serious injury risk.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), a prescription-only medication. The recall involves 41,863 cartons, each containing 3 wallets, distributed nationwide within the United States. The specific lot affected is H801227, with an expiration date of January 2020.

The recall was initiated due to complaints that the tablets crumble when popped out of the blister pack. This failure in tablet specifications poses a risk to patients using the medication.

Consumers who have this specific lot of Blisovi Fe 1.5/30 should stop using it and contact their healthcare provider or pharmacist for a replacement or further instructions.

The recalled product

Product
Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11

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: H801227
  • Exp. Date January 2020

Distribution

Distributed nationwide across the United States.