Amneal Recalls Tramadol HCl Tablets Due to NDSRI Impurity

Amneal Pharmaceuticals, LLC

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0408-2026 · 20260408 · Ongoing · Voluntary: Firm initiated

Product

traMADol Hydrochloride Tablets, USP, 50 mg, 500-count bottles, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382220, India, Distributed by: Amneal Pharmaceuticals LLC, Glas...

Reason for Recall

Failed Impurities/Degradation Specifications: N-nitroso-desmethyl-tramadol impurity (NDSRI) was found out of the specification at 24-month stability interval during Long term stability (25¿C/60%RH).

Affected Lot Numbers / Codes

Lot #: AM230987, Exp. Date 05/2026; AR232387, Exp. Date 12/2026.

Quantity

29,542 bottles

Distribution

Nationwide within the USA

Initiated

20260319

FDA Classified

20260330

Product Registration

Brand: TRAMADOL HYDROCHLORIDE

Manufacturer: Amneal Pharmaceuticals NY LLC

Application: ANDA076003

NDC: 60219-2348

Drug Label Context (from openFDA)

The following is from the manufacturer's FDA-approved drug label, not recall-specific. Provided for context.

Boxed Warning

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF TRAMADOL HYDROCHLORIDE TABLETS Addiction, Abuse and Misuse Because the use of tramadol hydrochloride tablets exposes patients and other users to the risks of opioid addiction, abuse and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1) ] . Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of tramadol hydrochloride tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of tramadol hydrochloride tablets are essen...

Indications & Usage

1 INDICATIONS AND USAGE Tramadol hydrochloride tablets are indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1) ] , reserve tramadol hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Hav...

Dosage & Administration

2 DOSAGE AND ADMINISTRATION Tramadol hydrochloride tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 ) Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Reserve titration to higher doses of tramadol hydrochloride tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) Initiate the dosing regimen for...

Contraindications

4 CONTRAINDICATIONS Tramadol hydrochloride tablets are contraindicated for: all children younger than 12 years of age [see Warnings and Precautions (5.6) ] . postoperative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy [see Warnings and Precautions (5.6) ] . Tramadol hydrochloride tablets are also contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.2) ] . Acute or severe bronchial asthma in an ...

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1) ] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2) ] Ultra-Rapid Metabolism of Tramadol and Other Risk Factors for Life-threatening Respiratory Depression in Children [see Warnings and Precautions (5.6) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4) ] ...

Drug Interactions

7 DRUG INTERACTIONS Table 2: Clinically Significant Drug Interactions with Tramadol Hydrochloride Tablets Inhibitors of CYP2D6 Clinical Impact: The concomitant use of tramadol hydrochloride tablets and CYP2D6 inhibitors may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1, particularly when an inhibitor is added after a stable dose of tramadol hydrochloride tablet is achieved. Since M1 is a more potent μ-opioid agonist, decreased M...

How Supplied

16 HOW SUPPLIED/STORAGE AND HANDLING Tramadol Hydrochloride Tablets USP, 50 mg are supplied as white, round film-coated tablets, debossed “AN” over “627” on one side and scored on other side. They are supplied as follows: Bottles of 10: NDC 60219-2348-4 Bottles of 100: NDC 60219-2348-1 Bottles of 500: NDC 60219-2348-5 Bottles of 1,000: NDC 60219-2348-7 Dispense in a tight container. Store at 20...

Sources: openFDA · Raw JSON