Drug recall: Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC

FDA enforcement event 68860 · Class III · initiated 11 Jul 2014 · status Terminated · terminated 10 Jul 2017

DrugVoluntary: Firm initiated1 product recordPrinceton, NJ

FDA enforcement event 68860 is a drug recall by Sandoz Inc of Princeton, NJ, initiated 11 Jul 2014 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. 27% of the 313 drug enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 10 Jul 2017. Initiation: voluntary: firm initiated. Sandoz Inc has 30 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 Inc, Princeton, NJ.

Reason for recall

"Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing."

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1445-2014	Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.	781,000 extended release tablets	Class III	Terminated	30 Jul 2014

Context

27%of 2014 drug events are Class III313 events that year

1product record in this eventfirm median: 1

30events on this register for the firm

Other enforcement events for 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

All 30 events for Sandoz Inc

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing."

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: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 10 Jul 2017. "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.