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Class IIIOngoing

Bionpharma Inc. recalls Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg

Recall date · record updated Sep 9, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Bionpharma Inc.
Reason
Presence of Foreign Tablets/Capsules
Hazard
FDA Class III: not likely to cause adverse health consequences (FDA definition).
Who’s affected
US Nationwide.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99551…

Products

  1. Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.

    Codes/lots: Lot # DMA25006, Exp Date: 11/30/2028.Quantity: 14,232 bottles (1,423,200 tablets)Recall no. D-0822-2026Class III

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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