Spectrum Laboratory Products recalls Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100
Spectrum recalls ranitidine hydrochloride powder (1g-1kg) due to NDMA impurity detected. This chemical may pose health risks. Affected lots expire October 2023.
Recall notice
CGMP Deviations: Presence of NDMA impurity detected in product.
Contact the company & request your remedy
What happened, in plain English
Spectrum Laboratory Products is recalling ranitidine hydrochloride powder (1g to 1kg) because it contains NDMA impurity. This chemical has been linked to potential health risks, so affected users should stop using the product. Read more at govinfonow.com/recall/37475-spectrum-ranitidine-powder-recall-ndma-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37475-spectrum-ranitidine-powder-recall-ndma-impurity-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0825-2020
Cite this page
“Spectrum Ranitidine Powder Recall: NDMA Impurity Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37475-spectrum-ranitidine-powder-recall-ndma-impurity-risk. Based on FDA recall #D-0825-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0825-2020%22&limit=1).
Why it’s dangerous
NDMA (N-nitrosodimethylamine) is a chemical that has been found in some ranitidine products and is classified as a probable human carcinogen by the International Agency for Research on Cancer. The presence of this impurity in the product may pose health risks, particularly with long-term use.
Who’s affected
Prescription drug users who purchased Spectrum ranitidine hydrochloride powder (1g to 1kg) between the time of manufacture and expiration date of October 2023. Patients using this medication for conditions like ulcers or acid reflux are most at risk.
How to tell if you have this one
Check for Spectrum Chemical Mfg Corp. labels with ranitidine hydrochloride powder (1g, 5g, 25g, 100g, 500g, or 1kg) that expired by October 2023. Lot number 11E0585 is also associated with this recall.
- Brand
Spectrum Laboratory Products- Category
Drug
What to do — step by step
Stop Using Product
Immediately stop using the recalled ranitidine hydrochloride powder if you have it.
Questions people ask
Is this product safe to use?
The recall record states that NDMA impurity was detected, but it does not specify whether the product is safe to use. The manufacturer has recalled it, so it is recommended to stop using it.
What should I do if I have this product?
The recall record does not provide specific instructions for disposal or return. You should stop using the product and contact your healthcare provider for alternative treatment options.
How can I check if I have the recalled product?
Check for Spectrum Chemical Mfg Corp. labels with ranitidine hydrochloride powder (1g to 1kg) that expired by October 2023, with lot number 11E0585.
Contact Spectrum Laboratory Products
We’ve drafted a message you can send Spectrum Laboratory Products to request your refund or repair — edit it as you like.
Subject: Recall D-0825-2020 — Spectrum Laboratory Products Spectrum Laboratory Products Hello, I own a Spectrum Laboratory Products that is covered by recall D-0825-2020 from Spectrum Laboratory Products. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0825-2020 (January 14, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0825-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.