Food, drugs, devices › Hetero Labs Limited (Unit V)
Drug recall: Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscat
Hetero Labs Limited (Unit V) (Badepalle, N/A) initiated this drug recall on 6 Aug 2020; FDA lists 1 product record under event 86191, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 64% of the 342 drug enforcement events initiated in 2020 carry the same class.
Status: Terminated, terminated 24 Jan 2022. Initiation: voluntary: firm initiated. Hetero Labs Limited (Unit V) has 7 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Hetero Labs Limited (Unit V), Badepalle, N/A, India.
Reason for recall
"Failed Tablet/Capsule Specification; complaint of bulging tablet"
Distribution
"Product was distributed to major wholesalers/distributors throughout the United States."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-1545-2020 | Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ by Hetero Labs, Limited, Mahabubragar, India | 43,512 bottles | Class II | Terminated | 2 Sep 2020 |
Context
Other enforcement events for Hetero Labs Limited (Unit V)
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 26 Mar 2026 | Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceu | Drug | Class II | 1 |
| 20 Aug 2018 | Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadch | Drug | Class II | 1 |
| 15 Aug 2018 | Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla | Drug | Class I | 1 |
| 8 Aug 2018 | Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, | Drug | Class II | 4 |
| 13 Feb 2018 | Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, | Drug | Class II | 2 |
| 22 Dec 2017 | Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08 | Drug | Class II | 1 |
All 7 events for Hetero Labs Limited (Unit V)
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Failed Tablet/Capsule Specification; complaint of bulging tablet"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed to major wholesalers/distributors throughout the United States."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 24 Jan 2022. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.