Hetero Labs Limited (Unit V) recalls
FDA enforcement reports naming Hetero Labs Limited (Unit V) as the recalling firm.
- Recall reports
- 11
- Class I (serious)
- 1
- Most recent report
- Apr 29, 2026
- Apr 29, 2026Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, M…Drug · Hetero Labs Limited (Unit V)Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."Class II
- Sep 2, 2020Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Cam…Drug · Hetero Labs Limited (Unit V)Failed Tablet/Capsule Specification; complaint of bulging tabletClass II
- Oct 3, 2018Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limi…Drug · Hetero Labs Limited Unit VLabeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.Class I
- Oct 3, 2018Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs…Drug · Hetero Labs Limited Unit VDiscoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.Class II
- Aug 29, 2018Camber Pharmaceuticals, IncDrug · Hetero Labs Limited Unit VCGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.Class II
- Aug 29, 2018Camber Pharmaceuticals, IncDrug · Hetero Labs Limited Unit VCGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.Class II
- Aug 29, 2018Camber Pharmaceuticals, IncDrug · Hetero Labs Limited Unit VCGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.Class II
- Aug 29, 2018Camber Pharmaceuticals, IncDrug · Hetero Labs Limited Unit VCGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.Class II
- Mar 21, 2018Valacyclovir Tablets USP 1 gram, 30-count bottle, Rx Only, Manufactured for Camber Phar…Drug · Hetero Labs Limited Unit VTemperature 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).Class II
- Mar 21, 2018Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Cambe…Drug · Hetero Labs Limited Unit VTemperature 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).Class II
- Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharma…
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