Food, drugs, devices › West-Ward Columbus Inc

Drug recall: Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Ea

FDA enforcement event 80364 · Class II · initiated 24 Jul 2018 · status Terminated · terminated 29 Apr 2020

DrugVoluntary: Firm initiated2 product recordsColumbus, OH

West-Ward Columbus Inc (Columbus, OH) initiated this drug recall on 24 Jul 2018; FDA lists 2 product records under event 80364, 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. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 29 Apr 2020. Initiation: voluntary: firm initiated. West-Ward Columbus Inc has 9 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

West-Ward Columbus Inc, Columbus, OH.

Reason for recall

"Failed Dissolution Specifications:"

Distribution

"Nationwide in the USA."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1024-2018	Doxycycline Hyclate Tablets, USP, 100 mg*. 50-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-50.	29,048 bottles (1,452,400 tablets)	Class II	Terminated	8 Aug 2018
D-1025-2018	Doxycycline Hyclate Tablets, USP, 100 mg*. 500-count bottle, Rx only. Manufactured by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724. NDC# 0143-2112-05.	29048 500-count bottles (14,524,000 tablets)	Class II	Terminated	8 Aug 2018

Context

60%of 2018 drug events are Class II367 events that year

2product records in this eventfirm median: 1

9events on this register for the firm

Other enforcement events for West-Ward Columbus Inc

Initiated	Product (first record)	Type	Class	Records
19 Dec 2024	Methadone Hydrochloride Tablets, USP, 5mg, 10x10 Unit-Dose Tablets, Rx Only, Distributed by: Hikma Pharmaceuticals USA I	Drug	Class III	1
22 Sep 2023	Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceutical	Drug	Class III	1
22 Jul 2020	Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatont	Drug	Class III	1
13 May 2020	Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 014	Drug	Class II	1
13 May 2020	Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatonto	Drug	Class III	1
9 Sep 2019	Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatont	Drug	Class II	1
4 Apr 2017	Doxercalciferol Capsules 0.5mcg, 50 count bottles, Rx, only, Manufactured by Cipla Limited Kurkumbh, Maharashtra, India,	Drug	Class III	1
19 May 2016	Oxycodone HCl, Oral Solution USP, 5 mg/5 mL, 15 mL bottles, Rx only, Boehringer Ingelheim Roxane, Inc., Columbus, OH ---	Drug	Class III	1

All 9 events for West-Ward Columbus Inc

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Dissolution Specifications:"

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: "Nationwide in the USA."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 29 Apr 2020. "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.