The Recall Desk
LowFDA (Drugs)·D-1080-2019·Announced 2019-04-10

Akorn Recalls Nystatin Oral Suspension Due to Unknown Impurity

Akorn, Inc. is recalling Nystatin Oral Suspension because an unknown impurity was detected during stability testing. The affected product was distributed in Arkansas and Mississippi.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this recall as Class III, which indicates that use of or exposure to the product is not likely to cause adverse health consequences. The issue is a documentation/stability specification failure rather than a direct safety hazard like contamination or mislabeling.

Plain-English summary

Akorn, Inc. is recalling Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, manufactured by HI-TECH Pharmacal Co., Inc. The recall involves 2,796 bottles of the prescription medication, identified by Lot #356527 with an expiration date of 3/19.

The recall was initiated because an out-of-specification result for an unknown impurity was observed during 18-month stability testing. The affected product was distributed in Arkansas (AR) and Mississippi (MS).

Consumers and healthcare providers should stop using the affected product and contact their pharmacist or physician for guidance on alternative treatments or returns.

The recalled product

Product
Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16
Manufacturer
Akorn, Inc.
Category
Drug — Antifungal
Hazard
Affected units
2,796

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 (2)

  • Lot#: 356527
  • Exp 3/19

Distribution

Distributed in 2 states:

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