CLASS II Drug recall · Reported 18 Mar 2020 · FDA Enforcement Report
Levonorgestrel and Ethinyl Estradiol Tablets recalled
Lupin Pharmaceuticals is recalling Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and, distributed nationwide in the US. The recall was initiated on 9 Mar 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1056-2020
- FDA event ID
- 85169
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Mar 2020
- FDA classified
- 24 Mar 2020
- Reported
- 18 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Hormones & Birth Control
Timeline
| 9 Mar 2020 | Recall initiated by company | |
| 18 Mar 2020 | Published in enforcement report | +9 days |
| 24 Mar 2020 | Classified by FDA | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it recalled?
Failed Content Uniformity Specifications: Out Of Specification test results observed for content uniformity.
Which lots are affected?
Lot #: L800951, Exp July 2020
Where was it sold?
Nationwide in the USA and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 85169| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Bekyree (desogestrel and ethinyl estradiol tablets recalled | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Lupin Pharmaceuticals
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|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
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| Drug | CLASS II | Liraglutide Injection, 18 mg/ (6 mg/mL) recalledLiraglutide | Lupin Pharmaceuticals | Particulate Matter | Nationwide |
| Drug | CLASS II | Sertraline Hydrochloride Tablets USP, 100 mg recalledSertraline Hydrochloride | Lupin Pharmaceuticals | Packaging Defects | Nationwide |
Other Levonorgestrel recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg recalled | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Altavera Levonorgestrel and Ethinyl Estradiol Tablets recalledAltavera | Xiromed | Labeling Errors | Nationwide |
| Drug | CLASS II | Option 2, Levonorgestrel Tablet, 1.5 mg, Emergency Contraceptive recalledOption 2 | L. Perrigo | Other | Nationwide |
| Drug | CLASS III | Lessina(R) (Levonorgestrel and ethinyl estradiol tablets recalledLessina | Teva Pharmaceuticals USA | Benzene | Nationwide |
| Drug | CLASS III | Portia (levonorgestrel and ethinyl estradiol) Tablets recalledPortia | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |