Skip to content
Lower risk Drug recall · FDA · Published December 20, 2021

American Health Packaging Metoprolol Tablets Recall: Failed Dissolution Specifications

American Health Packaging recalls 50mg Metoprolol Succinate Extended-Release Tablets due to failed dissolution specifications. This may affect medication effectiveness. Check NDC 68001-501-03 and specific lots for affected products.

🇺🇸 FDA recall #D-0451-2022DrugAmerican Health Packaging ›
Take action

Contact the company

Recalling firmAmerican Health Packaging2550 John Glenn Ave Ste A · Columbus, OH 43217-1188
✎ GovInfoNow plain-language explainer

American Health Packaging is recalling 50mg Metoprolol Succinate Extended-Release Tablets because they failed dissolution specifications. This could mean the medication doesn't work properly when taken as intended. Read more at govinfonow.com/recall/35421-american-health-packaging-metoprolol-tablets-recall-failed-dissolution-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/35421-american-health-packaging-metoprolol-tablets-recall-failed-dissolution-specifications · Updated August 18, 2026 · FDA enforcement record: FDA #D-0451-2022

Cite this page

“American Health Packaging Metoprolol Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35421-american-health-packaging-metoprolol-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0451-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0451-2022%22&limit=1).

The FDA announced on December 20, 2021, that American Health Packaging is recalling Metoprolol Succinate Extended-Release Tablets, USP 50 mg due to failed dissolution specifications. The recall affects 6,637 bottles distributed nationwide.

How to tell if you have it

  • Brand: American Health Packaging
  • Product: Metoprolol Succinate Extended-Release Tablets, USP 50 mg
  • Packaging: 500-count bottle
  • NDC: 68001-501-03
  • Lots: 21141983, 21141984, 21141985 (Exp 03/31/2023); 21142017, 21142018, 21142019 (Exp 02/28/2023)
  • Manufacturer: Alkem Laboratories Ltd.
  • Quantity: 6,637 bottles
  • Distribution: Nationwide in the USA

The hazard

The tablets failed dissolution specifications. The FDA classified this recall as Class II.

Context

GovInfoNow's records show American Health Packaging has 41 other recalls on record since July 23, 2012. Other recent recalls of similar products include American Health Packaging Buprenorphine Tablets Recall (August 19, 2026), American Health Packaging Nitrofurantoin Capsules Recall (May 3, 2022), and American Health Packaging Recalls Cyanocobalamin Injection (April 12, 2022). Other recent recalls of similar products include Teva Metoprolol Succinate Tablets Recall (January 29, 2026), Teva Metoprolol Succinate Extended-Release Tablets Recall (January 29, 2026), and Teva Recalls Metoprolol Succinate 50 mg (January 29, 2026).

How to tell if you have this one

Check for the NDC code 68001-501-03 on the bottle. The specific lots listed are 21141983, 21141984, 21141985 (expiring 03/31/2023) and 21142017, 21142018, 21142019 (expiring 02/28/2023).

  • Brand
    American Health Packaging
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the NDC code 68001-501-03 and the specific lots mentioned in the recall notice.

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 in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 15 months after the firm started it.

1. Firm started the recall: Dec 20, 202112. FDA classified it Class II: Jan 25, 202223. Published in FDA’s Enforcement Report: Feb 2, 202234. FDA terminated the recall: Mar 9, 2023420212023
  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.

Similar recalls

Other American Health Packaging recalls

Latest drug recalls

Keep exploring

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-0451-2022 (December 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0451-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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