Reported Mar 8, 2023 · Terminated

Finasteride Tablets USP, 5 mg, Rx Only, Packaged as

Accord Healthcare, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446

Is this the product you have?

Finasteride Tablets USP, 5 mg, Rx Only, Packaged as

4 of 4 products

Products covered by this recall
#Product as published
130-count bottles NDC 16729-090-10 UPC 3 16729 09010 0
290-count bottles NDC 16729-090-15 UPC 3 16729 09015 5
3100-count bottles NDC 16729-090-01 UPC 3 16729 09001 8
4500-count bottles NDC 16729-090-16 UPC 3 16729 09016 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
Lot codes and dates
  • Batches

    342 of 342 codes

    • a) P2001383
    • Exp. Date 2/28/2023
    • P2004886
    • Exp. Date 8/31/2023
    • P2100853
    • Exp. Date 11/30/2023
    • P2101652
    • Exp. Date 2/29/2024
    • P2101821
    • Exp. Date 2/29/2024
    • P2102146
    • Exp. Date 3/31/2024
    • P2107270
    • Exp. Date 10/31/2024
    • P2107939
    • Exp. Date 10/31/2024
    • P2201491
    • Exp. Date 2/28/2025
    • b) P2001377
    • Exp. Date 2/28/2023
    • P2005673
    • Exp. Date 9/30/2023
    • P2005911
    • Exp. Date 10/31/2023
    • P2005878
    • Exp. Date 10/31/2023
    • P2006076
    • Exp. Date 10/31/2023
    • P2006110
    • Exp. Date 10/31/2023
    • P2006830
    • Exp. Date 11/30/2023
    • P2100639
    • Exp. Date 1/31/2024
    • P2100640
    • Exp. Date 1/31/2024
    • P2104208
    • Exp. Date 6/30/2024
    • P2105388
    • Exp. Date 7/31/2024
    • P2105387
    • Exp. Date 7/31/2024
    • P2200316
    • Exp. Date 12/31/2024
    • P2200318
    • Exp. Date 12/31/2024
    • P2200317
    • Exp. Date 12/31/2024
    • P2200319
    • Exp. Date 12/31/2024
    • P2200820
    • Exp. Date 1/31/2025
    • P2200822
    • Exp. Date 1/31/2025
    • P2201492
    • Exp. Date 2/28/2025
    • P2201493
    • Exp. Date 2/28/2025
    • P2201758
    • Exp. Date 2/28/2025
Amount recalled
2,731,365 bottles

This recall covers 67 products

The agency filed one notice per product. You are reading one of them; the other 66 are below.

54 more are in the archive.

Where it was sold

Why it was recalled

CGMP Deviations: recalling drug products following an FDA inspection.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Apr 22, 2024 · Data as of Sep 19, 5:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.