Drug recall: Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx…

Class II FDA enforcement event 87154. Recall start date: 7 Jan 2021. Status in the FDA record: Terminated. Termination date: 3 Aug 2022.

Reason for recall, in the words of FDA

Failed Dissolution Specifications

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

American Health Packaging started this drug recall on 7 Jan 2021. The firm address in the FDA record is in Columbus, OH. FDA put the recall in Class II. FDA event 87154 has 1 product record. The first FDA enforcement report date is 27 Jan 2021. The record gives the status Terminated, with the termination date 3 Aug 2022.

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 USA

Recalling firm

American Health Packaging, Columbus, OH.

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 87154: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0232-2021	Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per carton (10 capsules x 10 blister cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC Carton: 68084-446-01; NDC Blister Card: 68084- 446-11	1948 cartons	Class II	Terminated	27 Jan 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: 1Median of the firm: 1
Events of the firm on the register: 42

Other events of the firm

Other FDA enforcement events of American Health Packaging
Initiated	Product (first record)	Type	Class	Records
19 Aug 2026	Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, C	Drug	Class III	1
3 May 2022	Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsules (10 x 10), 10-count blisters per card, 10	Drug	Class III	1
12 Apr 2022	Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutaneous Use Only, 25 x 1 mL Vials, Rx only, Ma	Drug	Class III	1
22 Feb 2022	Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Ins	Drug	Class II	1
20 Dec 2021	Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories	Drug	Class II	1
17 Sep 2021	GlipiZIDE Extended-Release Tablets, 2.5 mg, 30 Tablets (3 blister cards each with 10 individually blistered doses), Rx o	Drug	Class II	1
15 Sep 2021	Valproic Acid Oral Solution, USP, 500 mg/10 mL, 100 10 mL unit dose cups per case, Rx Only, Packaged and Distributed by:	Drug	Class II	1
12 May 2021	Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Heal	Drug	Class III	1
10 Jun 2020	Nabumetone Tablets, USP, 500 mg, 100 Tablets per carton (10 tablets x 10 blister cards), Rx only, Distributed by: Americ	Drug	Class III	1
19 May 2020	Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx only, Distributed by: American Health Packa	Drug	Class II	1

American Health Packaging: all 42 events

Official channels

FDA enforcement report D-0232-2021The 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 87154. https://recallregister.com/fda/ii/87154/. 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 USA
What quantity of product is in FDA event 87154?: The FDA record gives this quantity: 1948 cartons
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.