Hetero USA Inc

FDA recalling firm · 4 enforcement events · 4 product records · 2017–2023 · NJ

Hetero USA Inc has 4 FDA enforcement events on this register (4 product records) between 2017 and 2023: 4 drug; the busiest year was 2017 with 3.

0% of its events are Class I; the most common class is Class II (2). 1 event is listed as ongoing; the recalling firm's address is in NJ.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
14 Mar 2023	Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10	Drug	Class II	1	Ongoing
20 Jul 2017	Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854. By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India. NDC 31722-833-30	Drug	Class II	1	Terminated
27 Apr 2017	Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, by Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-778-01	Drug	Class III	1	Terminated
7 Jan 2017	Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: HETERO Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar - 509 301, India, NDC 31722-726-30	Drug	Class III	1	Terminated

By type and class

Drug4

Class II2

Class III2

Class I: 0% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Hetero USA Inc by year initiated.

Questions and answers

How many FDA recalls has Hetero USA Inc had?

4 enforcement events (4 product records) on this register, 2017–2023: 4 drug.

Are any Hetero USA Inc recalls ongoing?

1 event is listed as ongoing in the current openFDA export.

What class are Hetero USA Inc recalls?

2 Class II, 2 Class III. 0% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.