Food, drugs, devices › Teva Pharmaceuticals USA Inc

Drug recall: Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC

FDA enforcement event 90430 · Class II · initiated 14 Jun 2022 · status Terminated · terminated 27 Apr 2023

DrugVoluntary: Firm initiated1 product recordParsippany, NJ

FDA enforcement event 90430 is a drug recall by Teva Pharmaceuticals USA Inc of Parsippany, NJ, initiated 14 Jun 2022 and classified Class II, with 1 product record.

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. 65% of the 325 drug enforcement events initiated in 2022 carry the same class.

Status: Terminated, terminated 27 Apr 2023. 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 Dissolution Specifications; Low Out of Specification (OOS) results for dissolution."

Distribution

"Nationwide in the U.S."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1156-2022	Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.	4941 bottles	Class II	Terminated	29 Jun 2022

Context

65%of 2022 drug events are Class II325 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
6 Apr 2026	Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs	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

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 Dissolution Specifications; Low Out of Specification (OOS) results for dissolution."

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 U.S."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 27 Apr 2023. "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.