The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-406-2014·Announced 2014-01-22

Betachem Recalls Metformin Hydrochloride API Due to CGMP Deviations

Betachem, Inc. is recalling 27,000 kilos of Metformin Hydrochloride USP active pharmaceutical ingredient because it was not manufactured according to current good manufacturing practices.

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, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity recall involving potential quality issues without confirmed harm.

Plain-English summary

Betachem, Inc. is recalling 27,000 kilos (1,080 drums) of Metformin Hydrochloride USP, an active pharmaceutical ingredient (API) intended for manufacturing, processing, or re-packing use only. The product is distributed in 25 kg drums and is marked for prescription use only. The API was manufactured by Smruthi Organics Limited in India.

The recall was initiated because the active pharmaceutical ingredient was not manufactured according to current good manufacturing practices (CGMP). The source text does not specify the exact nature of the deviations or report any illnesses, injuries, or deaths associated with the product.

The affected product is distributed in Missouri (MO). Specific lot numbers involved in the recall include DMFH-366/11 through DMFH-406/11, with specific gaps in the sequence as listed in the source data. Because this is an active pharmaceutical ingredient for manufacturing use, it is not intended for direct consumer use. Healthcare facilities and manufacturers should stop using the affected lots and contact the recalling firm for instructions.

The recalled product

Product
Metformin Hydrochloride USP, Active Pharmaceutical Ingredient for manufacturing, processing or re-packing use only, 25 kg drum, Rx only, Manufactured by: Smruthi Organics Limited, Plot No.: A-27 M.I.D.C., Chincholi, Taq.: Mohol, Solapur-413 255. Maharashtra, India; NDC No.…
Manufacturer
Betachem, Inc.
Category
Drug — Active Pharmaceutical Ingredient
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 (20)

  • Lot #: DMFH-366/11
  • DMFH-367/11
  • DMFH-368/11
  • DMFH-369/11
  • DMFH-370/11
  • DMFH-371/11
  • DMFH-372/11
  • DMFH-373/11
  • DMFH-374/11
  • DMFH-375/11
  • DMFH-376/11
  • DMFH-393/11
  • DMFH-394/11
  • DMFH-395/11
  • DMFH-396/11
  • DMFH-397/11
  • DMFH-399/11
  • DMFH-400/11
  • DMFH-401/11
  • DMFH-402/11

Distribution

Distributed in 1 state:

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