Recall events
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Event 80773
Event summary
Timeline bucket August 08, 2018
Product types Drug
Classifications Class II
Statuses Completed
Recalling firm wording Hetero Labs Limited Unit V
Dossier provenance
Source snapshots represented here
openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
How coverage and grouping work
Device root-cause evidence is not applicable to this event.
No grouped product has the official product type device; this is not an unavailable-enrichment finding.
Complete imported group
Every recalled product in this event
4 official enforcement rows
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 4
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
D-1113-2018
Recall number D-1113-2018
Initiated August 08, 2018
Classification Class II
Status Completed
Quantity 316,380 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information All Lots with expiration dates 7/2018 to 6/2020
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14076]
FDA event record
· Exact recall-number query on openFDA
drug · product 2 of 4
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
D-1114-2018
Recall number D-1114-2018
Initiated August 08, 2018
Classification Class II
Status Completed
Quantity 394,896 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information All Lots with expiration dates 7/2018 to 6/2020
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14032]
FDA event record
· Exact recall-number query on openFDA
drug · product 3 of 4
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
D-1115-2018
Recall number D-1115-2018
Initiated August 08, 2018
Classification Class II
Status Completed
Quantity 441,408 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information All Lots with expiration dates 7/2018 to 6/2020
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[15051]
FDA event record
· Exact recall-number query on openFDA
drug · product 4 of 4
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
D-1116-2018
Recall number D-1116-2018
Initiated August 08, 2018
Classification Class II
Status Completed
Quantity 441,408 bottles
App-derived interpretation
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0
CGMP Deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information All Lots with expiration dates 7/2018 to 6/2020
Distribution pattern Nationwide
Official fact provenance
Dataset openFDA Drug Enforcement
Snapshot published July 16, 2026 07:03
Snapshot SHA-256 b791303a96cde04f35218bb062dc99bbd2aaedb7873ee857564b5dbe373c2651
Raw source locator 0001-drug-enforcement-0001-of-0001.json.zip#results[14776]
FDA event record
· Exact recall-number query on openFDA
