FDA Drug Recalls October 2026 — Paroxetine, Ranolazine, Estradiol

FDA Drug Recalls — October 2026

Published October 15, 2026 · Sources: FDA Enforcement Reports

⚠ Three Class II Recalls Active: The FDA has issued recalls for specific lots of paroxetine (generic Paxil), ranolazine (generic Ranexa), and estradiol gel. These recalls affect medications distributed nationwide. Check your lot numbers below.

1. Paroxetine Extended-Release Tablets, 37.5 mg

Failed Dissolution Specifications

Drug: Paroxetine HCl Extended-Release Tablets, 37.5 mg (generic Paxil CR)

Manufacturer: Apotex Corp., Weston, FL

Recall Class: Class II (may cause temporary or reversible health consequences)

Affected Lot: TY9495, Exp. 05/2027

NDC: 60505-1318-3 (30-count bottle)

Distribution: US Nationwide

Reason: The tablets failed dissolution testing. Tablets that do not dissolve properly may not release the correct amount of medication, which could lead to reduced effectiveness in treating depression, anxiety, or other conditions paroxetine is prescribed for.

FDA Recall #: D-0877-2026

2. Ranolazine Extended-Release Tablets, 1000 mg

Failed Dissolution Specifications

Drug: Ranolazine Extended-Release Tablets, 1000 mg (generic Ranexa)

Manufacturer: Ajanta Pharma USA Inc., Bridgewater, NJ

Recall Class: Class II

Affected Lot: DJ25134, Exp. 11/2028

NDC: 27241-126-02 (60-count bottle)

Distribution: US Nationwide

Reason: The tablets failed dissolution testing (below specification). Ranolazine treats chronic angina (chest pain). Tablets that do not dissolve correctly may deliver less medication than intended, which could reduce the drug's ability to control angina symptoms.

FDA Recall #: D-0010-2027

3. Estradiol Gel, 0.1%

Defective Containers

Drug: Estradiol Gel, 0.1%, 0.25 mg (30 packets per carton)

Manufacturer: Amneal Pharmaceuticals LLC, Bridgewater, NJ

Recall Class: Class II

Affected Lot: 245226005B, Exp. 04/2028

NDC: 69238-2452-3

Quantity: 2,592 cartons (30-count)

Distribution: US Nationwide

Reason: Packets were found to be either empty or only partially full. Estradiol gel is a hormone replacement therapy for menopausal symptoms. Patients using packets from this lot may receive less than the prescribed dose.

FDA Recall #: D-0873-2026

✅ What You Should Do:

Check the lot number on your medication bottle or packet against the numbers listed above.
If your lot matches, do not stop taking your medication without talking to your doctor or pharmacist first.
Contact your pharmacy for a replacement from a different lot.
Report any adverse effects to the FDA MedWatch program at fda.gov/medwatch or call 1-800-FDA-1088.

View all FDA safety alerts →

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