Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber
Hetero Labs Limited Unit V recalls Camber Pharmaceuticals Valsartan 320mg tablets due to detected carcinogen impurity in manufacturing. Affected lots expire 7/2018 to 6/2020. Stop using immediately.
Recall notice
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Contact the company & request your remedy
What happened, in plain English
Hetero Labs Limited Unit V is recalling Camber Pharmaceuticals Valsartan 320mg tablets because a carcinogen impurity was found in the drug product. This poses a risk of potential cancer exposure with long-term use. Affected products have specific lot numbers and expiration dates. Read more at govinfonow.com/recall/39747-hetero-labs-valsartan-tablets-recall-carcinogen-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39747-hetero-labs-valsartan-tablets-recall-carcinogen-impurity-risk · Updated October 6, 2026 · FDA enforcement record: FDA #D-1116-2018
Cite this page
“Hetero Labs Valsartan Tablets Recall: Carcinogen Impurity Risk.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39747-hetero-labs-valsartan-tablets-recall-carcinogen-impurity-risk. Based on FDA recall #D-1116-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1116-2018%22&limit=1).
Why it’s dangerous
The recall is due to a carcinogen impurity detected in the active pharmaceutical ingredient used to make the drug. This impurity could potentially lead to cancer with long-term use of the medication. The impurity was found during manufacturing quality control checks.
Who’s affected
Prescription drug users who have the specific Camber Valsartan 320mg tablets with expiration dates from July 2018 to June 2020. Patients on blood pressure medication are most at risk.
How to tell if you have this one
Check for the product name 'Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only' with NDC code 31722-748-90. The expiration dates range from July 2018 to June 2020.
- Brand
Hetero Labs Limited Unit V- Product
Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Completed- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-1113-2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307; All Lots with expiration dates 7/2018 to 6/2020 | 316,380 bottles | 31722-745-30, 31722-745-90, 31722-745-05, 31722-745-31, 31722-745-32, 31722-746-30, 31722-746-90, 31722-746-05, 31722-746-31, 31722-746-32, 31722-747-30, 31722-747-90, 31722-747-05, 31722-747-31, 31722-747-32, 31722-748-30, 31722-748-90, 31722-748-05, 31722-748-31, 31722-748-32, 3317227453 |
| D-1114-2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-746-90 UPC 331722746908; All Lots with expiration dates 7/2018 to 6/2020 | 394,896 bottles | 31722-745-30, 31722-745-90, 31722-745-05, 31722-745-31, 31722-745-32, 31722-746-30, 31722-746-90, 31722-746-05, 31722-746-31, 31722-746-32, 31722-747-30, 31722-747-90, 31722-747-05, 31722-747-31, 31722-747-32, 31722-748-30, 31722-748-90, 31722-748-05, 31722-748-31, 31722-748-32, 3317227469 |
| D-1115-2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905; All Lots with expiration dates 7/2018 to 6/2020 | 441,408 bottles | 31722-745-30, 31722-745-90, 31722-745-05, 31722-745-31, 31722-745-32, 31722-746-30, 31722-746-90, 31722-746-05, 31722-746-31, 31722-746-32, 31722-747-30, 31722-747-90, 31722-747-05, 31722-747-31, 31722-747-32, 31722-748-30, 31722-748-90, 31722-748-05, 31722-748-31, 31722-748-32, 3317227479 |
| D-1116-2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Pollepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-748-90 UPC 331722748902; All Lots with expiration dates 7/2018 to 6/2020 | 441,408 bottles | 31722-745-30, 31722-745-90, 31722-745-05, 31722-745-31, 31722-745-32, 31722-746-30, 31722-746-90, 31722-746-05, 31722-746-31, 31722-746-32, 31722-747-30, 31722-747-90, 31722-747-05, 31722-747-31, 31722-747-32, 31722-748-30, 31722-748-90, 31722-748-05, 31722-748-31, 31722-748-32, 3317227489 |
What to do — step by step
Stop Using Immediately
Discard all affected tablets as they contain a carcinogen impurity that could pose cancer risks with long-term use.
Questions people ask
Why is this medication being recalled?
The recall is due to a carcinogen impurity detected in the active pharmaceutical ingredient used to manufacture the drug product.
What is the specific product affected?
Camber Pharmaceuticals Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only with NDC 31722-748-90 and expiration dates from July 2018 to June 2020.
How can I check if I have the affected product?
Check for the product name 'Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only' with NDC code 31722-748-90 and expiration dates from July 2018 to June 2020.
Contact Hetero Labs Limited Unit V
We’ve drafted a message you can send Hetero Labs Limited Unit V to request your refund or repair — edit it as you like.
Subject: Recall D-1116-2018 — Hetero Labs Limited Unit V Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsarta Hello, I own a Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber that is covered by recall D-1116-2018 from Hetero Labs Limited Unit V. 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-1116-2018 (August 8, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1116-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.