RecallRadar

FDA Drug recall D-1056-2020

Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (N…

On 2020-03-18 the FDA classified a Class II recall of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (N… by Lupin Pharmaceuticals, citing failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1056-2020
ClassificationClass II
Statusterminated
Initiated2020-03-09
Published2020-03-18
Last updated2026-09-13 11:52 UTC
CompanyLupin Pharmaceuticals
DistributionUS

Product

Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.

Reason

Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.

Identifiers

code_infoLot #: L800951, Exp July 2020

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1056-2020%22

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