Drug recall: Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc.…

Class II FDA enforcement event 88884. Recall start date: 19 Oct 2021. Status in the FDA record: Terminated. Termination date: 18 Jun 2024.

Reason for recall, in the words of FDA

Defective Container

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

Teligent Pharma, Inc. started this drug recall on 19 Oct 2021. The firm address in the FDA record is in Buena, NJ. FDA put the recall in Class II. FDA event 88884 has 2 product records. The first FDA enforcement report date is 1 Dec 2021. The record gives the status Terminated, with the termination date 18 Jun 2024.

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 within the United States

Recalling firm

Teligent Pharma, Inc., Buena, 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 88884: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0258-2022	Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05	2664 bottles	Class II	Terminated	1 Dec 2021
D-0259-2022	Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05.	5400 units	Class II	Terminated	1 Dec 2021

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 2021: 299
Share of these events in Class II: 60%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 19

Other events of the firm

Other FDA enforcement events of Teligent Pharma, Inc.
Initiated	Product (first record)	Type	Class	Records
15 Mar 2022	Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b)	Drug	Class II	37
7 Feb 2022	Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Di	Drug	Class II	1
30 Nov 2021	Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured	Drug	Class I	2
12 Oct 2021	Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Phar	Drug	Class I	3
23 Aug 2021	Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NJ	Drug	Class II	1
3 Aug 2021	Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey	Drug	Class I	1
29 Jul 2021	Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New	Drug	Class III	1
29 Jul 2021	Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59	Drug	Class II	1
19 Jul 2021	Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-02	Drug	Class II	2
22 Jun 2021	Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59	Drug	Class III	2

Teligent Pharma, Inc.: all 19 events

Official channels

FDA enforcement report D-0258-2022The 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 88884. https://recallregister.com/fda/ii/88884/. 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 within the United States
What quantity of product is in FDA event 88884?: The event has 2 product records. The first record gives this quantity: 2664 bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2021 have the same class?: 60% of the 299 drug events that started in 2021 are in Class II.