Digoxin Tablets, USP 125mcg, (0.125 mg), 1000-count bottle, Rx Only, Manufactured by…

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Recalling firm

Novitium Pharma LLC

NDC code

70954-201-20

Origin

NJ, United States

Initiated by

Voluntary: Firm initiated

FDA recall number

D-0389-2024

Other East recalls

See all

Class II · Moderate risk Ongoing Aug 4, 2026

Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834…

Reason Failed Dissolution Specifications

Novartis Pharmaceuticals Corporation NDC 0078-0359-34 D-0746-2026

Class II · Moderate risk Ongoing Jul 30, 2026

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

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

Heritage Pharmaceuticals Inc NDC 23155-603-51 D-0768-2026

Class II · Moderate risk Ongoing Jul 23, 2026

Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279…

Reason shortfill; reports of empty capsules.

Aurobindo Pharma USA Inc NDC 59651-719-99 D-0733-2026

Class II · Moderate risk Ongoing Jul 13, 2026

Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc…

Reason Presence of Precipitate: medication was crystallizing and particles floating in the bottle

Rising Pharma Holding, Inc. NDC 64980-504-48 D-0724-2026

Class I · High risk Ongoing Jun 24, 2026

Cetirizine Hydrochloride Tablets USP 5 mg, 100-count bottle, Manufactured by: Unique Pharmaceuticals Labs, (A Div. of J.B…

Reason Cross Contamination with Other Products: Customer complaints for appearance of discolored tablets and red dots observed on Cetirizine Hydrochloride…

JB Chemicals and Pharmaceuticals Ltd NDC 16571-401-10 D-0732-2026