AVKARE recalls 80mg/5mg Telmisartan and Amlodipine tablets (Rx only) due to potential impurities from long-term stability testing. These prescription blood pressure medications may pose safety risks if stored improperly.
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
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📍Recalling firmAVKARE Inc.615 N 1st St · Pulaski, TN 38478-2403
✎ GovInfoNow plain-language explainer
AVKARE is recalling prescription Telmisartan and Amlodipine tablets (80mg/5mg, 30 tablets) because they may contain impurities that could affect safety. This recall is for patients using these blood pressure medications who have the specific product details listed. Read more at govinfonow.com/recall/38957-avkare-telmisartan-amlodipine-tablets-80mg-5mg-impurities-risk.
“AVKARE Telmisartan/Amlodipine Tablets 80mg/5mg: Impurities Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38957-avkare-telmisartan-amlodipine-tablets-80mg-5mg-impurities-risk. Based on FDA recall #D-1122-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1122-2019%22&limit=1).
AVKARE Inc. voluntarily recalled Telmisartan and Amlodipine Tablets 80 mg/5 mg on April 3, 2019, due to failed impurity specifications, the FDA said. The Class III recall involved 397 bottles distributed in Arizona and Colorado.
How to tell if you have it
Brand: AVKARE
Product: Telmisartan and Amlodipine Tablets 80 mg/5 mg
Quantity: 30 tablets per bottle
NDC: 42291-795-30
Lot codes: 201916, 20092
Expiration dates: 08/2019
Distribution: AZ, CO
The hazard
The recall was initiated because the Telmisartan and Amlodipine Tablets failed impurity specifications based on an 18-month long-term stability study conducted by the manufacturer.
Context
GovInfoNow's records show AVKARE Inc. has 21 other recalls on record since Feb. 27, 2015. Other recent recalls of similar products include AvKARE Rosuvastatin Tablets 10mg Recall: Dissolution Issue (Dec. 31, 2025) and Ajanta Pharma Fluphenazine Tablets Recall: Impurity Risk in 100-Count Bottles (Aug. 25, 2026). Previous AVKARE recalls include a Lamotrigine 100mg recall due to labeling errors on July 20, 2022, and a Phytonadione Tablets 5mg recall for impurity risk on June 9, 2021.
How to tell if you have this one
Check for the NDC code 42291-795-30 on the product label. The lot numbers are 201916 (expiring 08/2019) or 20092 (expiring 08/2019). These tablets are prescription-only.
Brand
AVKARE
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the NDC code 42291-795-30 and lot numbers 201916 or 20092 on your prescription bottle.
Where it went and when
Where it was distributed
Distributed in Arizona and Colorado.
Listed by the agency
Not listed
FDA distribution: “AZ, CO” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, Colorado.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-1122-2019 (April 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1122-2019 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.