Food, drugs, devices › Teva Pharmaceuticals USA, Inc

Drug recall: Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs

FDA enforcement event 98730 · Class II · initiated 6 Apr 2026 · status Ongoing

DrugVoluntary: Firm initiated1 product recordParsippany, NJ

Teva Pharmaceuticals USA, Inc (Parsippany, NJ) initiated this drug recall on 6 Apr 2026; FDA lists 1 product record under event 98730, 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. 74% of the 234 drug enforcement events initiated in 2026 carry the same class.

Status: Ongoing. Initiation: voluntary: firm initiated. Teva Pharmaceuticals USA, Inc has 60 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

Teva Pharmaceuticals USA, Inc, Parsippany, NJ.

Reason for recall

"Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin"

Distribution

"Nationwide in the USA, Puerto Rico and Virgin Islands"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0521-2026	Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.	5,101 cartons	Class II	Ongoing	29 Apr 2026

Context

74%of 2026 drug events are Class II234 events that year

1product record in this eventfirm median: 1

60events on this register for the firm

Other enforcement events for Teva Pharmaceuticals USA, Inc

Initiated	Product (first record)	Type	Class	Records
24 Aug 2026	traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zag	Drug	Class II	1
24 Apr 2026	Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing: 8-mL	Drug	Class II	1
19 Mar 2026	Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx Only, Manufact	Drug	Class II	3
17 Mar 2026	Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx onl	Drug	Class II	3
29 Jan 2026	Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles	Drug	Class II	4
12 Jan 2026	Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc.	Drug	Class II	2
7 Nov 2025	Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavi	Drug	Class III	1
13 Oct 2025	Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when reconstituted), Rx o	Drug	Class II	1
7 Oct 2025	Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194	Drug	Class II	3
23 May 2025	Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva Hrvatska, d.o.o., Zageb,	Drug	Class II	1

All 60 events for Teva Pharmaceuticals USA, Inc

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin"

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, Puerto Rico and Virgin Islands"

Is the recall still ongoing?

FDA lists the status as Ongoing. "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.