Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 16714-0849-03 recalled?

Clomipramine Hydrochloride · 100 CAPSULE in 1 BOTTLE (16714-849-03)

Yes — this exact package was recalled

1 FDA recall names the code 16714-0849-03 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

1 of these recalls is still ongoing.

Active ingredient
Clomipramine Hydrochloride
Strength
CLOMIPRAMINE HYDROCHLORIDE 25 mg/1
Form
Capsule · Oral
Labeler
Northstar Rx LLC.
Type
Human Prescription Drug
Product code
16714-0849

Recalls naming this package

Class II · Moderate risk

clomiPRAMINE Hydrochloride

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

Ongoing Nitrosamine impurity Zydus Pharmaceuticals (USA) Inc NDC 16714-849-01 D-0152-2026

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler