FLUPHENAZINE HYDROCHLORIDE Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marke Recall 2026
FLUPHENAZINE HYDROCHLORIDEIssued August 25, 2026
FLUPHENAZINE HYDROCHLORIDE Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01. — recalled per FDA on 8/25/2026. Reason: Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent..
What to do about this recall
- Agency
- FDA
- Issued
- Aug 25, 2026
- Brand
- FLUPHENAZINE HYDROCHLORIDE
- Distribution
- 1 states
- Lots affected
- 4
Steps to take for this recall
Stop using it
Take it out of rotation. Don't consume, wear, or operate.
Verify the match
Compare lot numbers, UPCs, and dates against your product.
Return or dispose
Follow the manufacturer's instructions to refund or safely dispose.
What's recalled
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.
Why it was recalled
Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
Affected products & lot numbers4 lots called out
Affected Lot Numbers
Check your product label — do not use if your lot number appears below.
| Lot Number |
|---|
| Lot #: DJ23254 |
| Exp. Date 11/30/2026 |
| DJ10205 |
| Exp. Date 04/30/2027. |
Where was it sold1 state
Nationwide within the U.S
More recalls like this4 related — by brand, contaminant, and category
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Frequently asked questions
Is the FLUPHENAZINE HYDROCHLORIDE recall still active?
Yes, this recall is currently active as of August 25, 2026. Do not use or consume the affected product.
What lot numbers are affected?
Affected lot numbers: Lot #: DJ23254, Exp. Date 11/30/2026, DJ10205, Exp. Date 04/30/2027.. Check the label on your product.
What should I do if I have the recalled FLUPHENAZINE HYDROCHLORIDE?
Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.