Fluphenazine Hydrochloride Tablets recall
FDA recall D-0836-2026 · initiated Aug 25, 2026
Ajanta Pharma USA Inc recalled Fluphenazine Hydrochloride Tablets in Aug 2026 — an FDA Class III recall (D-0836-2026) because 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.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 403,200 tablets
Details
- Product
- 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.
- Recalling company
- Ajanta Pharma Ltd
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the U.S
- Initiated
- Aug 25, 2026
- FDA report date
- Sep 16, 2026
Frequently asked
- Was Fluphenazine Hydrochloride Tablets recalled?
- Ajanta Pharma USA Inc recalled Fluphenazine Hydrochloride Tablets in Aug 2026 — an FDA Class III recall (D-0836-2026) because 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. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Fluphenazine Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0836-2026 was: 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.
- Is a recalled Fluphenazine Hydrochloride Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Fluphenazine Hydrochloride Tablets are affected?
- Distributed: Nationwide within the U.S. The recall covers these lots — Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0836-2026.