The Recall Desk
SevereFDA (Drugs)·D-0525-2020·Announced 2019-12-04

AVKARE Recalls Ranitidine Tablets Due to NDMA Impurity

AVKARE Inc. is recalling specific lots of Ranitidine Tablets 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant potential hazards like NDMA impurities, even without reported injuries.

Plain-English summary

AVKARE Inc. is recalling 104,797 bottles of AVKARE Ranitidine Tablets, USP 300 mg. The recall affects two specific NDC numbers: 42291-725-25 (250 tablets) and 42291-725-30 (30 tablets). The products were distributed nationwide.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the impurity N-nitrosodimethylamine (NDMA) was found in the active pharmaceutical ingredient (API). The source text does not report any illnesses or injuries associated with this recall.

Consumers should check their medication bottles for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or pharmacist for guidance on alternatives.

The recalled product

Product
AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, Inc. Pulaski, TN 38478 a) 250 tablets NDC 42291-725-25; b) 30 tablets NDC 42291-725-30
Manufacturer
AVKARE Inc.
Category
Drug — Prescription Medication
Hazard
Affected units
104,797

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (14)

  • Lots: a) 21307 Exp. 02/29/2020
  • 21309 Exp. 02/29/2020
  • 21528 Exp. 02/29/2020
  • 21527 Exp. 02/29/2020
  • 22247 Exp. 06/30/2020
  • 23214 Exp. 09/30/2020
  • 23243 Exp. 09/30/2020
  • 23244 Exp. 11/30/2020
  • 24198 Exp. 01/31/2021
  • 24199 Exp. 01/31/2021
  • 24289 Exp. 01/31/2021
  • b) 22291 Exp. 06/30/2020
  • 23215 Exp. 09/30/2020
  • 23776 Exp. 01/31/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by AVKARE Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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Same hazard · ndma impurity

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