Food, drugs, devices › Sandoz Incorporated

Drug recall: Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC

FDA enforcement event 77567 · Class III · initiated 16 Jun 2017 · status Terminated · terminated 14 Jan 2019

DrugVoluntary: Firm initiated1 product recordBroomfield, CO

FDA enforcement event 77567 is a drug recall by Sandoz Incorporated of Broomfield, CO, initiated 16 Jun 2017 and classified Class III, with 1 product record.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 30% of the 343 drug enforcement events initiated in 2017 carry the same class.

Status: Terminated, terminated 14 Jan 2019. Initiation: voluntary: firm initiated. Sandoz Incorporated has 15 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

Sandoz Incorporated, Broomfield, CO.

Reason for recall

"Cross Contamination With Other Product: Imipramine"

Distribution

"Product was distributed throughout the United States"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0943-2017	Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC 0781-1487-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540	38,234 bottles	Class III	Terminated	12 Jul 2017

Context

30%of 2017 drug events are Class III343 events that year

1product record in this eventfirm median: 1

15events on this register for the firm

Other enforcement events for Sandoz Incorporated

Initiated	Product (first record)	Type	Class	Records
6 Apr 2018	Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc.,	Drug	Class III	1
22 Dec 2016	Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, ND	Drug	Class II	1
5 Dec 2014	Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01	Drug	Class III	1
25 Jul 2014	Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10	Drug	Class II	1
22 Oct 2013	Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz	Drug	Class II	1
25 Sep 2013	Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC	Drug	Class III	1
7 Aug 2013	Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit cart	Drug	Class III	1
21 Jun 2013	Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactu	Drug	Class II	1
30 May 2013	Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by S	Drug	Class II	1
20 May 2013	Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for:	Drug	Class I	1

All 15 events for Sandoz Incorporated

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Cross Contamination With Other Product: Imipramine"

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Product was distributed throughout the United States"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 14 Jan 2019. "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.