Dr. Reddy's Famotidine Tablets Recall: Impurity Risk in 10mg Bottles
Dr. Reddy's recalls 10mg Famotidine tablets with impurity 8 detected in stability testing. Affected lots from CVS Pharmacy and Wal-Mart stores. Consumers should check labels for NDC codes and expiration dates.
Lower-risk recall
Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
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What happened, in plain English
Dr. Reddy's is recalling 10mg Famotidine tablets that tested positive for an impurity during stability checks. This impurity could potentially cause harm if taken long-term, but the risk is not immediate. Read more at govinfonow.com/recall/41159-dr-reddy-s-famotidine-tablets-recall-impurity-risk-in-10mg.
Source Summary by GovInfoNow · govinfonow.com/recall/41159-dr-reddy-s-famotidine-tablets-recall-impurity-risk-in-10mg · Updated October 7, 2026 · FDA enforcement record: FDA #D-0009-2018
Cite this page
“Dr. Reddy's Famotidine Tablets Recall: Impurity Risk in 10mg Bottles.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41159-dr-reddy-s-famotidine-tablets-recall-impurity-risk-in-10mg. Based on FDA recall #D-0009-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0009-2018%22&limit=1).
Why it’s dangerous
During routine stability testing, a specific impurity (impurity 8) was found in some batches of Famotidine tablets. This impurity could potentially cause harm if taken long-term, but the risk is not immediate.
Who’s affected
People who bought Famotidine tablets labeled as CVS Pharmacy Acid Controller or Equate Famotidine from CVS Pharmacy or Wal-Mart stores. Those with chronic acid-related conditions may be at slightly higher risk.
How to tell if you have this one
Check for the product label: 'CVS Pharmacy Acid Controller' or 'Equate Famotidine'. Look for NDC codes 55111-118-30 or 49035-118-30. The expiration dates range from October 2017 to May 2018.
- Brand
Dr. Reddy's- Category
Drug
What to do — step by step
Check Product Label
Look for the label 'CVS Pharmacy Acid Controller' or 'Equate Famotidine' on the bottle.
Verify Expiration Date
Confirm the expiration date matches the listed dates (October 2017 to May 2018) for the affected lots.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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-0009-2018 (October 3, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0009-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.