Class II FDA drug recall · D-0460-2023

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05) and c) 1,000-count bottle (NDC 51991-0706-10), Rx only, Manufactured by Centaur Pharmaceuticals PVT. LTD., Hinjewadi, Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037.

Why it was recalled

CGMP Deviations: Potential risk of Cross Contamination

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

Lot # 5210645, exp. date 3/31/2023, 500's Bottle 5210646, exp. date 3/31/2023, 500's Bottle 5210647, exp. date 3/31/2023, 500's Bottle  5210648, exp. date 3/31/2023, 1000's Bottle 5210649, exp. date 3/31/2023, 1000's Bottle  5210831, exp. date 4/30/2023, 100's Bottle  5210832, exp. date 4/30/2023, 500's Bottle 5210833, exp. date 4/30/2023, 500's Bottle  5210834, exp. date 4/30/2023, 1000's Bottle 5210835, exp. date 4/30/2023, 1000's Bottle  5210905, exp. date 5/31/2023, 100's Bottle 5210906, exp. date 5/31/2023, 100's Bottle  5210907, exp. date 5/31/2023, 500's Bottle 5210908, exp. date 5/31/2023, 500's Bottle 5210909, exp. date 5/31/2023, 500's Bottle 5210965, exp. date 5/31/2023, 500's Bottle  5210997, exp. date 5/31/2023, 1000's Bottle 5210998, exp. date 5/31/2023, 1000's Bottle 5211175, exp. date 6/30/2023, 1000's Bottle  5211176, exp. date 6/30/2023, 500's Bottle 5211177, exp. date 6/30/2023, 500's Bottle 5211178, exp. date 6/30/2023, 500's Bottle 5211179, exp. date 6/30/2023, 500's Bottle 5211180, exp. date 6/30/2023, 500's Bottle 5211181, exp. date 6/30/2023, 500's Bottle 5211205, exp. date 7/31/2023, 500 s Bottle 5211206, exp. date 7/31/2023, 500's Bottle  5211227, exp. date 7/31/2023, 1000's Bottle  5211228, exp. date 7/31/2023, 100's Bottle  5211229, exp. date 7/31/2023, 1000's Bottle  5211334, exp. date 8/31/2024, 500's Bottle  5211335, exp. date 8/31/2024, 1000's Bottle  5211456, exp. date 8/31/2024 , 500's Bottle 5211457, exp. date 8/31/2024 , 500's Bottle 5211458, exp. date 8/31/2024, 500's Bottle  5211459, exp. date 9/30/2024, 1000's Bottle  5211727, exp. date 11/30/2024, 100's Bottle  5211730, exp. date 11/30/2024, 1000's Bottle 5220028, exp. date 12/31/2024, 1000's Bottle 5220029, exp. date 12/31/2024, 1000's Bottle  5220288, exp. date 2/28/2025, 100's Bottle

Recall status

Terminated — the FDA has closed the recall; the firm's corrective actions were judged effective.

Where it was distributed

USA nationwide.

Recall record

Recalling firm: Breckenridge Pharmaceutical, Inc
Product type: Drugs
Recall number: D-0460-2023
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Berlin, CT
Recall initiated: 2023-03-02
Terminated: 2024-03-21

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall D-0460-2023 · Source: openFDA enforcement.