Drug recall: L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged…

Class II FDA enforcement event 75654. Recall start date: 9 Nov 2016. Status in the FDA record: Terminated. Termination date: 17 Oct 2017.

Reason for recall, in the words of FDA

Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.

Class II, in the words of FDA

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

Sandoz Inc started this drug recall on 9 Nov 2016. The firm address in the FDA record is in Princeton, NJ. FDA put the recall in Class II. FDA event 75654 has 2 product records. The first FDA enforcement report date is 23 Nov 2016. The record gives the status Terminated, with the termination date 17 Oct 2017.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide throughout the USA

Recalling firm

Sandoz Inc, Princeton, NJ.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 75654: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0140-2017	L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.	18,751 vials	Class II	Terminated	23 Nov 2016
D-0141-2017	L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.	33,624 vials	Class II	Terminated	23 Nov 2016

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2016: 288
Share of these events in Class II: 46%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 30

Other events of the firm

Other FDA enforcement events of Sandoz Inc
Initiated	Product (first record)	Type	Class	Records
1 Jun 2026	Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDM	Drug	Class III	1
5 Sep 2025	Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactur	Drug	Class II	1
13 Aug 2025	Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manuf	Drug	Class II	1
27 Jun 2025	Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by S	Drug	Class I	2
21 Mar 2022	Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton,	Drug	Class II	1
17 Nov 2021	Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Inje	Drug	Class I	1
21 Apr 2020	Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed	Drug	Class II	1
17 Oct 2019	Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC	Drug	Class III	3
23 Sep 2019	Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of	Drug	Class II	3
2 Nov 2018	Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01);	Drug	Class II	6

Sandoz Inc: all 30 events

Official channels

FDA enforcement report D-0140-2017The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 75654. https://recallregister.com/fda/ii/75654/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide throughout the USA
What quantity of product is in FDA event 75654?: The event has 2 product records. The first record gives this quantity: 18,751 vials
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2016 have the same class?: 46% of the 288 drug events that started in 2016 are in Class II.