The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0537-2018·Announced 2018-02-28

FDA Recalls Methylcobalamin Due to Missing Stability Data

American Pharmaceutical Ingredients LLC is recalling Methylcobalamin (Vitamin B12) for prescription compounding because the manufacturer lacked stability data to support the assigned expiration dates.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant regulatory deviations like missing stability data that could impact product safety.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Methylcobalamin (Vitamin B12) intended for prescription compounding. The product is manufactured by American Pharmaceutical Ingredients LLC and is available in various package sizes, including 500mg, 1g, 5g, 10g, 25g, and 100g. The recall covers approximately 10,769 grams of the product distributed nationwide within the United States.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the manufacturer lacked the necessary stability data and controls to support the retest or expiration dates assigned to the product in its container/closure system. This deficiency means the assigned expiration dates may not be valid.

Healthcare professionals and pharmacies should stop using the affected lots immediately. Consumers who have purchased this product should contact their healthcare provider or pharmacist for guidance on whether to discontinue use. The affected lots include specific expiration dates ranging from 2019 to 2021, as detailed in the recall notice.

The recalled product

Product
Methylcobalamin (Vitamin B12) for prescription compounding, packaged in a) 500mg (NDC 58597-8142-1); b) 1g (NDC 58597-8056-2); c) 5g (NDC 58597-8056-3); d) 10g (NDC 58597-8056-4), e) 25 g (NDC 58597-8056-4); f) 100g (NDC 58597-8056-6), RX only, packed by American Pharmaceutical…
Manufacturer
American Pharmaceutical Ingredients LLC
Category
Drug — Pharmaceutical Ingredient
Hazard
Affected units
10,769

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 (15)

  • Lot #: a) b) 012216-1
  • Exp. 12/31/2019
  • 051515-3
  • Exp. 02/28/2019
  • c) 012216-1
  • Exp. 02/28/2019 d) 012216-1
  • 051515-2
  • 061516-1
  • Exp. 01/31/2020
  • e) 051515-2
  • exp. 02/28/2019
  • 082117A-1
  • Exp. 05/31/2021
  • f) 012216-1
  • 051515-1

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 66 recalled by American Pharmaceutical Ingredients LLC 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 66 products in this recall →

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