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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 85169

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 09, 2020
Product types
Drug
Classifications
Class II and Class III
Statuses
Terminated
Recalling firm wording
Lupin Pharmaceuticals Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454775, INDIA.

D-1055-2020
Recall number
D-1055-2020
Initiated
March 09, 2020
Classification
Class III
Status
Terminated
Quantity
1,712 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out Of Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: L800915, Exp July 2020

Distribution pattern

Nationwide in the USA and Puerto Rico.

drug · product 2 of 2

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.

D-1056-2020
Recall number
D-1056-2020
Initiated
March 09, 2020
Classification
Class II
Status
Terminated
Quantity
9,897 cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out Of Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

Lot #: L800951, Exp July 2020

Distribution pattern

Nationwide in the USA and Puerto Rico.