Alprazolam Tablets, USP, 1 mg, CIV
Medicine recall D-0460-2023. Published in FDA’s Enforcement Report on Mar 22, 2023.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Mar 22, 2023. Copied from openFDA on Oct 20, 2026.
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
CGMP Deviations: Potential risk of Cross Contamination
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
How much: “N/A”, in FDA’s words.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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.…
Every code shown here, 1,788 characters
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
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Barcodes and drug codes
-
NDC
51991-0706-01 -
NDC
51991-0706-05 -
NDC
51991-0706-10
As FDA’s description and codes give them; the UPCs written as digits only.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
USA nationwide.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 2, 2023.
- FDA classified it on Mar 10, 2023.
- FDA’s Enforcement Report published it on Mar 22, 2023.
- FDA terminated it on Mar 21, 2024.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Breckenridge Pharmaceutical, Inc, of Berlin, CT.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Drug recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Drug recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.