The Recall Registry
Recall data checked 13 hours ago

Home › Prescription medicine › SUN PHARMACEUTICAL INDUSTRIES INC —…

Food & drug recall · FDAJuly 9, 2024Serious

SUN PHARMACEUTICAL INDUSTRIES INC — Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

Failed Dissolution Specifications

The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC

The product

Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun - 248-197, Uttarakhand, India. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-233-88.

Details

Units affected
5752 bottles
Recall date
July 9, 2024
Brand
SUN PHARMACEUTICAL INDUSTRIES INC
Model, lot or SKU numbers
Lot #s: 231067, 231069, Exp 04/30/2025
Where it was distributed

Nationwide in the USA and Puerto rico

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: “SUN PHARMACEUTICAL INDUSTRIES INC — Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, Rx Only, 100 capsules per bottle, Manufactured by: Sidmak Laboratories (India) Pvt. Ltd. Plot No. 20, Pharmacity, Selaqui Industrial Area, Dehradun -”

Read it on FDA →

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

Other prescription medicine recalls