RecallReported September 9, 2026
Class III recall by Bionpharma Inc.
Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionp…
FDA's enforcement report of September 9, 2026 lists a Class III recall by Bionpharma Inc. of Princeton, NJ. Product: Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionp…. Status: Ongoing.
On the record
- Recalling firm
- Bionpharma Inc.
- Location
- Princeton, NJ
- Classification
- Class III
- Status
- Ongoing
- Recall number
- D-0822-2026
- Product type
- Drugs
- Brand names
- DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
- Generic names
- DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE
- Recall initiated
- 2026-08-07
- Reported by FDA
- 2026-09-09
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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