Lupin My Way Birth Control Tablets: Unapproved 2-Pack Configuration
Lupin Pharmaceuticals recalls My Way (Levonorgestrel) 2-pack birth control tablets that were marketed without FDA approval. Consumers should check product details and contact Lupin for guidance.
Recall notice
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
Contact the company
What happened, in plain English
Lupin Pharmaceuticals is recalling My Way birth control tablets sold in 2-packs that were not approved by the FDA. This means the product may not be safe for use as intended. Read more at govinfonow.com/recall/40528-lupin-my-way-birth-control-tablets-unapproved-2-pack-configuration.
Source Summary by GovInfoNow · govinfonow.com/recall/40528-lupin-my-way-birth-control-tablets-unapproved-2-pack-configuration · Updated October 7, 2026 · FDA enforcement record: FDA #D-0837-2018
Cite this page
“Lupin My Way Birth Control Tablets: Unapproved 2-Pack Configuration.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40528-lupin-my-way-birth-control-tablets-unapproved-2-pack-configuration. Based on FDA recall #D-0837-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0837-2018%22&limit=1).
Why it’s dangerous
The product was marketed without receiving the necessary FDA approval for its 2-pack configuration. This means it might not be safe for use as intended, potentially leading to health risks if used without proper regulatory oversight.
Who’s affected
Women who own or use My Way birth control tablets in 2-packs with the specific lot numbers and expiration date listed in the recall notice are affected. Women using these products without proper regulatory approval may face health risks.
How to tell if you have this one
Check for the product name 'My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each' with lot numbers M16317A1, M16317A4, M16317A5 and expiration date 11/18.
- Brand
Lupin Pharmaceuticals- Product
My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0837-2018 | My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.; Lot #: M16317A1, M16317A4, M16317A5, Exp 11/18 | 43,922 cartons |
| D-0838-2018 | My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212 4.; Lot #: L700329, Exp 08/19; L700670, Exp 11/19 | 43,640 cartons |
What to do — step by step
Check Product Details
Look for the specific lot numbers M16317A1, M16317A4, M16317A5 and expiration date 11/18 on the packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class II
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0837-2018 (May 17, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0837-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.