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Hetero Labs Limited (Unit V) Recalls
11 recalls on record · February 21, 2018 to April 29, 2026 · Drugs
Recalls by year
18
20
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 29, 2026DrugsFDA
Hetero Labs Limited (Unit V) recalls Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceu
Hazard: Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
September 2, 2020DrugsFDA
Hetero Labs Limited (Unit V) recalls Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscat
Hazard: Failed Tablet/Capsule Specification; complaint of bulging tablet
October 3, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadc
Hazard: Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
October 3, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla
Hazard: Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
August 29, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 320 mg, 90 tablets, Rx Only Manufactured for: Camber Pharmaceutic
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 29, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceutica
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 29, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmac
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 29, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceutical
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
March 21, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ
Hazard: Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
March 21, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscatawa
Hazard: Temperature Abuse: Valganciclovir Tablets USP 450 mg and Valacyclovir Tablets USP 1 gram were exposed to higher temperature at airport or cargo and in the same consignment of Famciclovir complaint batch (D-0415-2018).
February 21, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08
Hazard: Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution.