Prescription medicine recalls

Prescription medicine · Amgen, Inc. · 934577 bottles affected

Amgen, Inc. — Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 55513-800-99), and b) 60 tablet bottles (NDC 55513-800-60), Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy.

Presence of Foreign Substance.

Prescription medicine · Amgen, Inc. · 9565 bottles affected

Amgen, Inc. — Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only

CGMP Deviations

Prescription medicine · Lupin Pharmaceuticals Inc. · 2,530,182 bottles affected

Lupin Pharmaceuticals Inc. — prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04)

Presence of Foreign Substance

Why this is here: It was found to contain a drug or chemical that is not on the label. That is different from an allergen or a contamination scare: anyone taking it has been taking a substance nobody prescribed, in an unknown dose, and it can interact with medication they are already on. Follow the agency notice rather than judging it by how the product looks.

Prescription medicine · Elevate Oral Care · 8132 6-packs & 2262 2-packs affected

Elevate Oral Care — Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LLC, 346 Pike Road, Suite 6, West Palm Beach, FL 33411, NDC 57511-0611-1.

sub potency

Prescription medicine · Amgen, Inc. · N/A affected

Amgen, Inc. — Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Thousand Oaks, CA 92130 Made In Italy. NDC 55513-810-60

Presence of Foreign Substance.

Prescription medicine · Breckenridge Pharmaceutical, Inc. · 14,729 bottles. affected

Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, Rx only

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Prescription medicine · Amgen, Inc. · N/A affected

Amgen, Inc. — Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only

CGMP Deviations

Food & drug recall · FDAJune 3, 2026Labelling issue

Amneal Pharmaceuticals, LLC — Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only

Prescription medicine · Amneal Pharmaceuticals, LLC · 27,936 100-count bottles affected

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

Prescription medicine · Dabur India Limited · 84 tubes affected

Dabur India Limited — Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 52924 00683 1.

CGMP Deviations; deficiencies observed during FDA inspection

Prescription medicine · Dabur India Limited · 4,738 tubes affected

Dabur India Limited — Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes

CGMP Deviations; deficiencies observed during FDA inspection

Food & drug recall · FDAJune 2, 2026Labelling issue

ANI Pharmaceuticals, Inc. — hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only

Prescription medicine · ANI Pharmaceuticals, Inc. · 6564 bottles affected

Presence of foreign substance

Prescription medicine · Dabur India Limited · 1102 tubes affected

Dabur India Limited — Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net Wt. 1.5 oz (42.5g) Tubes

CGMP Deviations; deficiencies observed during FDA inspection

Prescription medicine · Dabur India Limited · 5755 tubes affected

Dabur India Limited — Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g)

CGMP Deviations; deficiencies observed during FDA inspection

Prescription medicine · Dabur India Limited · 4,944 tubes affected

Dabur India Limited — Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes

CGMP Deviations; deficiencies observed during FDA inspection

Food & drug recall · FDAJune 1, 2026Labelling issue

Sandoz Inc — Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only

Prescription medicine · Sandoz Inc · 7,803 bottles affected

Labeling: Incorrect or Missing Lot and/or Exp Date

Food & drug recall · FDAJune 1, 2026Serious

Ascend Laboratories, LLC — Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bottle, Rx Only

Prescription medicine · Ascend Laboratories, LLC · 360 30-count bottles affected

Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9th month of dissolution test analysis

Prescription medicine · Gasco Industrial Corp. · N/A affected

Gasco Industrial Corp. — Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 1360, Gurabo PR 00778, UPC 7 87302 12363 6.

Subpotent drug

Prescription medicine · Gasco Industrial Corp. · N/A affected

Gasco Industrial Corp. — Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter)

Subpotent drug

Prescription medicine · Golden State Medical Supply Inc. · 2,961 bottles affected

Golden State Medical Supply Inc. — GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only

Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at…