Ajanta Pharma recall: Fluphenazine Hydrochloride Tablets
Ajanta Pharma USA Inc is recalling Fluphenazine Hydrochloride Tablets – 403,200 tablets. The U.S. Food and Drug Administration published the recall on September 16, 2026; it began on August 25, 2026. Distributed nationwide.
Lower risk Class III means using the product is not likely to cause health problems; it breaks a labeling or manufacturing rule.
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| Product | Fluphenazine Hydrochloride Tablets |
| Brand | Ajanta Pharma |
| Company | Ajanta Pharma USA Inc |
| Type | Drugs |
| Classification | Class III |
| Recall date | August 25, 2026 |
| Published by FDA | September 16, 2026 |
| Quantity | 403,200 tablets |
| Recall ID | 99733 |
Recalled products
- 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.
- FDA recall number
- D-0836-2026
- Codes, lots and dates
- Lot #: DJ23254, Exp. Date 11/30/2026; DJ10205, Exp. Date 04/30/2027.
- Quantity
- 403,200 tablets
- Classification
- Class III
Identifiers and details
- FDA event ID
- 99733
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Bridgewater, NJ, United States
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “Nationwide within the U.S”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99733, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Ajanta Pharma recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Ajanta Pharma recall: Ranolazine Extended-Release TabletsDrugs | Failed Dissolution Specifications: below specification Serious | FDA Class II |
Other drug recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 | Par Health recall: Buprenorphine HydrochlorideDrugs · 154210 bottles | Crystallization Serious | FDA Class II |
| Oct 7, 2026 | Apotex recall: Paroxetine Extended-Release TabletsDrugs | Failed dissolution specifications. Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
| Oct 7, 2026 | SV Labs Toronto recall: Benzoyl Peroxide WashDrugs | microbial contamination Serious | FDA Class II |
About this recall
Is Ajanta Pharma Fluphenazine Hydrochloride Tablets recalled?
Yes. Ajanta Pharma USA Inc recalled it on August 25, 2026; FDA published it September 16, 2026 (Class III). Only the lots, dates or models listed on this page are included.
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.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.