The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0914-2018·Announced 2018-03-14

Ranitidine Tablets Recalled for Failed Stability Specifications

Mckesson Packaging Services is recalling Ranitidine Tablets 150 mg due to failed stability specifications. The recall affects 17,192 cartons distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II. The source text does not report any illnesses, injuries, or specific adverse health consequences, and the hazard is related to stability specifications rather than a known high-risk pathogen or structural defect.

Plain-English summary

Mckesson Packaging Services is recalling Ranitidine Tablets, USP 150 mg, manufactured by Amneal Pharmaceuticals. The recall is due to failed stability specifications. The affected product is prescription-only and is packaged in cartons of 100 tablets (10x10).

The recall involves 17,192 cartons, totaling 1,719,200 tablets. The affected lots are 0113064 (Exp. 03/2018), 0114628 (Exp. 08/2018), 0115189 (Exp. 08/2018), and 0115462 (Exp. 09/2018). The product was distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and return it to the pharmacy or point of purchase. The FDA classifies this recall as Class II, indicating a situation that may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
RANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10
Manufacturer
Mckesson Packaging Services
Category
Drug — Prescription Medication
Hazard

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 (4)

  • Lots: 0113064 Exp. 03/2018
  • 0114628 Exp. 08/2018
  • 0115189 Exp. 08/2018
  • 0115462 Exp. 09/2018

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · Mckesson Packaging Services

See all →

Same hazard · stability failure

See all →

Similar recalls