Amneal Rabeprazole Tablets Recall: Failed Dissolution Specifications
Amneal Pharmaceuticals recalls 20mg Rabeprazole Sodium Delayed Release Tablets due to failed dissolution specifications. Rx-only tablets with specific NDC numbers and expiration dates are affected. Consumers should contact the manufacturer for details.
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Failed Dissolution Specifications
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What happened, in plain English
Amneal Pharmaceuticals is recalling 20mg Rabeprazole Sodium Delayed Release Tablets that failed dissolution tests. This means the medication may not work as intended when taken. The recall affects specific bottle sizes and production lots with expiration dates through September 2017 and May 2018. Read more at govinfonow.com/recall/42131-amneal-rabeprazole-tablets-recall-failed-dissolution-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/42131-amneal-rabeprazole-tablets-recall-failed-dissolution-specifications · Updated October 8, 2026 · FDA enforcement record: FDA #D-0693-2017
Cite this page
“Amneal Rabeprazole Tablets Recall: Failed Dissolution Specifications.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42131-amneal-rabeprazole-tablets-recall-failed-dissolution-specifications. Based on FDA recall #D-0693-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0693-2017%22&limit=1).
Why it’s dangerous
The tablets failed dissolution specifications, meaning they may not release the medication properly in the stomach. This could lead to ineffective treatment for conditions like GERD or ulcers. However, the recall does not indicate immediate harm to users.
Who’s affected
Prescription drug users who have the specific 30-count or 90-count bottles with the listed NDC numbers and expiration dates. Patients on long-term treatment for acid-related conditions are most at risk.
How to tell if you have this one
Check for 30-count or 90-count bottles labeled 'Rabeprazole Sodium Delayed Release Tablets, 20 mg' with NDC numbers 65162-0724-03 or 65162-0724-09. The expiration dates range from September 2017 to May 2018.
- Brand
Amneal- Category
Drug
What to do — step by step
Check Product Details
Identify the NDC number and expiration date on the bottle to confirm if it's affected.
Contact Manufacturer
Reach out to Amneal Pharmaceuticals for further instructions on what to do with the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the US and PR” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.3 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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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-0693-2017 (December 12, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0693-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.