Alvogen Nifedipine Tablets Recall: Cross Contamination Risk
Alvogen recalls 90mg Nifedipine Extended-Release Tablets due to cross contamination with sorafenib. Affected lots from 03/2018 to 10/2018. Stop using if you have these specific lots.
Recall notice
Cross Contamination with another product:residual powder found in inlet air duct identified as sorafenib
Contact the company
What happened, in plain English
Alvogen is recalling 90mg Nifedipine Extended-Release Tablets that may contain sorafenib due to cross contamination. This could pose a risk if taken by patients with certain conditions. The recall affects specific lots manufactured between March 2018 and October 2018. Read more at govinfonow.com/recall/41824-alvogen-nifedipine-tablets-recall-cross-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41824-alvogen-nifedipine-tablets-recall-cross-contamination-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0631-2017
Cite this page
“Alvogen Nifedipine Tablets Recall: Cross Contamination Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41824-alvogen-nifedipine-tablets-recall-cross-contamination-risk. Based on FDA recall #D-0631-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0631-2017%22&limit=1).
Why it’s dangerous
The tablets may contain residual sorafenib from another product due to cross contamination during manufacturing. Sorafenib is a different medication that could cause serious health issues if taken by patients who should not be using it.
Who’s affected
Patients prescribed Nifedipine Extended-Release Tablets by a doctor who have the affected lots. Those with specific health conditions that could be impacted by sorafenib contamination are at higher risk.
How to tell if you have this one
Check your Nifedipine Extended-Release Tablets for the lot numbers BXH1P51, BXH66D1, BXH1P51A, BXH5ZS1 (expiring 03/2018), BXH1P52 (expiring 05/2018), BXHBKF1A, or BXHB8S1A (expiring 10/2018).
- Brand
Alvogen- Category
Drug
All 9 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 III- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots |
|---|---|
| D-0627-2017 | Nifedipine Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-368-01.; Lot #: BXH1P22, BXH1P21A, BXH1P21, BXH1P31, BXH1P21B, Exp. 11/2017; BXH6EL1, BXH66A1, BXH6EN1, BXH6EP1, BXH6ER1, Exp. 06/2018; BXH81K1A, BXHBJD1A, Exp. 10/2018 |
| D-0628-2017 | Adalat CC (nifedipine) Extended Release Tablets 30 mg, 100-count bottles, Rx only, Manufactured for Bayer Healthcare Bayer Healthcare Pharmaceuticals Inc. Whippany, NJ 07901 Manufactured in Germany, NDC 50419-701-05; Lot #: BXH1P21A, Exp. 11/2017 |
| D-0629-2017 | Adalat CC (nifedipine) Extended Release Tablets, 60 mg, 100- count bottles, Rx only Manufactured for Almatica, Almatica Pharma Inc. Pinebrook, NJ 07058 USA, NDC 50419-702-05; Lot #: BXH1BE1A, BXH1P41A, Exp. 01/2018. |
| D-0630-2017 | Nifedipine Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-369-01.; Lot #: BXH1P41, BXH1BEE1, BXH1BE2, BXH1BE1B, BXH1BE1A, BXH1P41A, Exp. 01/2018; BXH81R1, BXHBD41A, BXH5ZR1, BXH9AL1A, Exp. 06/2018; BXHCUD1A, BXHCUF2A, Exp. 01/2019. |
| D-0631-2017 | Nifedipine Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Alvogen Inc. Pine Brook, NJ 07058 USA, NDC 47781-370-01.; Lot #: BXH1P51, BXH66D1, BXH1P51A, BXH5ZS1, Exp. 03/2018; BXH1P52, Exp. 05/2018; BXHBKF1A, and BXHB8S1A, Exp. 10/2018. |
| D-0632-2017 | Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 50419-70305; Lot #: BXH66D1A, Exp. 03/2018 |
| D-0633-2017 | Adalat CC (nifedipine) Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749401; Lot #: BXHBJD1A, Exp. 10/2018 |
| D-0634-2017 | Adalat CC (nifedipine) Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749501; Lot #: BXCUE1A, Exp. 01/2019 |
| D-0635-2017 | Adalat CC (nifedipine) Extended-Release Tablets, 90 mg, 100-count bottles, Rx Only, Manufactured for Almatica Pharma Inc. Pine Brook, NJ 07058 USA, NDC 5242749601; Lot #: BXHD7U1A, Exp. 10/2018 |
What to do — step by step
Check Your Lot Number
Look for the lot numbers BXH1P51, BXH66D1, BXH1P51A, BXH5ZS1 (expiring 03/2018), BXH1P52 (expiring 05/2018), BXHBKF1A, or BXHB8S1A (expiring 10/2018) on the bottle.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- 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-0631-2017 (March 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0631-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.