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Unrated Drug recall · FDA · Published February 15, 2022

ANI Pharmaceuticals Recalls 0.5mg Alprazolam Tablets Due to Manufacturing Deviations

ANI Pharmaceuticals recalls 0.5mg Alprazolam tablets with specific NDC codes and expiration dates due to cGMP deviations. Affected products may not meet quality standards.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0565-2022DrugANI Pharmaceuticals ›
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Contact the company

Recalling firmANI Pharmaceuticals, Inc.210 W Main St · Baudette, MN 56623-2467
✎ GovInfoNow plain-language explainer

ANI Pharmaceuticals is recalling 0.5mg Alprazolam tablets in specific bottle counts and lot numbers because of manufacturing deviations. This could affect product quality and safety. Read more at govinfonow.com/recall/35218-ani-pharmaceuticals-recalls-0-5mg-alprazolam-tablets-due-to-manufacturing.

Source Summary by GovInfoNow · govinfonow.com/recall/35218-ani-pharmaceuticals-recalls-0-5mg-alprazolam-tablets-due-to-manufacturing · Updated August 17, 2026 · FDA enforcement record: FDA #D-0565-2022

Cite this page

“ANI Pharmaceuticals Recalls 0.5mg Alprazolam Tablets Due to Manufacturing Deviations.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/35218-ani-pharmaceuticals-recalls-0-5mg-alprazolam-tablets-due-to-manufacturing. Based on FDA recall #D-0565-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0565-2022%22&limit=1).

ANI Pharmaceuticals, Inc. recalled Alprazolam Tablets, USP 0.5 mg on Feb. 15, 2022, due to current good manufacturing practice deviations, the FDA said. Owners should contact the company for a refund.

How to tell if you have it

  • Brand: ANI Pharmaceuticals
  • Product: Alprazolam Tablets, USP 0.5 mg
  • NDC 67253-901-10 (100-count bottles)
  • NDC 67253-901-50 (500-count bottles)
  • NDC 67253-901-11 (1000-count bottles)
  • Lot #19B029A, Exp. Date 02/2022
  • Lot #19D021A, Exp. Date 04/2022
  • Lots 19A087B, 19A088B, 19A089B, 19A090B, Exp. Date 02/2022
  • Lots 19A086B, 19A091B, 19B019B, Exp. Date 02/2022
  • Lots 19B020C, 19B021C, 19B027C, 19B028C, Exp. Date 02/2022
  • Lots 19E056C, 19E057C, Exp. Date 05/2022
  • Lot #19E059C, Exp. Date 06/2022
  • Lot #19G072C, Exp. Date 07/2022
  • Distributed nationwide within the United States

The hazard

The recall was issued due to current good manufacturing practice deviations. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show ANI Pharmaceuticals has three other recalls on record since Oct. 9, 2020. Other recent recalls of similar products include ANI Pharmaceuticals' June 2, 2026, hydrOXYzine oral solution recall due to a foreign substance and its May 12, 2026, Estradiol Gel recall due to defective containers.

How to tell if you have this one

Check the product label for the NDC codes 67253-901-10, 67253-901-50, or 67253-901-11 and expiration dates listed in the recall notice. The tablets are prescription-only and distributed by Par Pharmaceutical.

  • Brand
    ANI Pharmaceuticals
  • Category
    Drug
FDA recall event · 5 products

All 5 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Nationwide within the United States
Recall numberProduct, codes & lotsQuantity
D-0564-2022Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977; Lot #: a) 19C003A, Exp. Date 03/2022; 19G002A, exp. date 07/2022; b) 19C004B, Exp. Date 03/2022; c) 19C048C, Exp. Date 03/202273,920 bottles
D-0565-2022Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977; Lot #: a) 19B029A, Exp. Date 02/2022; 19D021A, Exp. Date 04/2022. b) 19A087B, 19A088B, 19A089B, 19A090B, Exp. Date 02/2022; 19A086B, 19A091B, 19B019B, Exp. Date 02/2022. c) 19B020C, 19B021C, 19B027C, 19B028C, Exp. Date 02/2022, 19E056C, 19E057C, Exp. Date 05/2022; 19E059C, Exp. Date 06/2022 19G072C, Exp. Date 07/2022205,662 bottles
D-0566-2022Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and c) 1000-count bottles (NDC 67253-902-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977; Lot #: a) 19B081A, Exp. Date 02/2022; 19E088A, 19E089A, Exp. Date 05/2022 b) 19A102B, Exp. Date 02/2022; 19D067B, 19D068B, Exp. Date 04/2022; 19D070C, Exp. Date 05/2022. c) 19F045C, 19F046C, Exp. Date 06/2022; 19B082C, 19B083C, Exp. Date 03/2022; 19D069C, Exp. Date 05/2022.173,499 bottles
D-0567-2022Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977; Lot #: a) 19C002A, Exp. Date 03/2022; 19E012A, 19E013A, Exp. Date 05/2022. b) 19C100B, Exp. Date 04/2022; 19E001B, 19E002B, Exp. Date 05/2022.70,788 bottles
D-0568-2022Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10.; Lot #: 19B064A, Exp. Date 03/20225,477 bottles
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the NDC codes 67253-901-10, 67253-901-50, or 67253-901-11 and expiration dates matching the recall list.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 8 months after the firm started it.

1. Firm started the recall: Feb 15, 202212. FDA classified it Class II: Feb 17, 202223. Published in FDA’s Enforcement Report: Feb 23, 202234. FDA terminated the recall: Oct 25, 202242022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Other ANI Pharmaceuticals recalls

ANI Pharmaceuticals, Inc. recalls hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI
June 2, 2026ANI Pharmaceuticals, Inc. recalls Estradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distributed by: ANI Pharmaceuticals,
May 12, 2026

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0565-2022 (February 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0565-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA