Drug recall: CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet…

Class II FDA enforcement event 99526. Recall start date: 30 Jul 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.

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

Heritage Pharmaceuticals Inc started this drug recall on 30 Jul 2026. The firm address in the FDA record is in East Brunswick, NJ. FDA put the recall in Class II. FDA event 99526 has 1 product record. The first FDA enforcement report date is 19 Aug 2026. The record gives the status Ongoing.

FDA enforcement report The 1 product record

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 U.S

Recalling firm

Heritage Pharmaceuticals Inc, East Brunswick, NJ.

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

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

Products

1 product record in the event.

FDA event 99526: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0768-2026	CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51		Class II	Ongoing	19 Aug 2026

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 2026: 234
Share of these events in Class II: 74%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 12

Other events of the firm

Other FDA enforcement events of Heritage Pharmaceuticals Inc
Initiated	Product (first record)	Type	Class	Records
6 Oct 2025	Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Priv	Drug	Class II	6
23 Nov 2022	Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick	Drug	Class II	1
21 Apr 2021	Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 0881	Drug	Class III	1
23 Oct 2020	Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc.	Drug	Class III	1
21 May 2019	PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hi	Drug	Class I	2
3 May 2019	Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Li	Drug	Class II	5
15 Feb 2019	Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals	Drug	Class II	1
2 Jan 2019	Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjaw	Drug	Class II	1
15 Oct 2018	Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawad	Drug	Class II	1
25 Mar 2015	GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage P	Drug	Class II	1

Heritage Pharmaceuticals Inc: all 12 events

Official channels

FDA enforcement report D-0768-2026The 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 99526. https://recallregister.com/fda/ii/99526/. 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 U.S
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2026 have the same class?: 74% of the 234 drug events that started in 2026 are in Class II.
How many FDA recalls does Heritage Pharmaceuticals Inc have?: Heritage Pharmaceuticals Inc is the recalling firm in 12 enforcement events on this register. This event is 1 of them.