CLASS III ONGOING Drug recall · Reported 16 Sep 2026 · FDA Enforcement Report
Fluphenazine Hydrochloride Tablets, USP, 1mg recalled
Ajanta Pharma USA is recalling Fluphenazine Hydrochloride Tablets, USP, 1mg, distributed nationwide in the US. The recall was initiated on 25 Aug 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0836-2026
- FDA event ID
- 99733
- Recalling firm
- Ajanta Pharma USA, Bridgewater, NJ
- Manufacturer
- Ajanta Pharma USA Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 25 Aug 2026
- FDA classified
- 8 Sep 2026
- Reported
- 16 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 25 Aug 2026 | Recall initiated by company | |
| 8 Sep 2026 | Classified by FDA | +14 days |
| 16 Sep 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide within the U.S
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
Where was it sold?
Nationwide within the U.S
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ajanta Pharma USA
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|---|---|---|---|---|---|
| Drug | CLASS II | Ranolazine Extended-Release Tablets, 1000 mg recalledRanolazine | Ajanta Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Fenofibrate Capsules, USP 200 mg recalled by Ajanta Pharma USAFenofibrate | Ajanta Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Aripiprazole Tablets recalled by Ajanta Pharma USAAripiprazole | Ajanta Pharma USA | Packaging Defects | Nationwide |
Other Fluphenazine recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 2.5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 10 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 20 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |