The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1543-2020·Announced 2020-09-02

Bayshore Pharmaceuticals Recalls Metformin Hydrochloride Tablets Due to CGMP Deviations

Bayshore Pharmaceuticals is voluntarily recalling 594 bottles of Metformin Hydrochloride Extended-Release Tablets due to Current Good Manufacturing Practice (CGMP) deviations.

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 source text explicitly states the agency classification is Class II. Per the rubric, if the agency's own classification is FDA Class II, the score must be at least 4 (Severe), even though no specific injuries are reported.

Plain-English summary

Bayshore Pharmaceuticals has initiated a voluntary recall of 594 bottles of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg. The affected product is identified by Lot #18641 and has an expiration date of 05/2021. The tablets are manufactured by Beximco Pharmaceuticals, LTD. in Bangladesh and are distributed under NDC 76385-128-10.

The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II, which indicates a situation that may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

The affected product was distributed nationwide. Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.

The recalled product

Product
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
Brand
METFORMIN HYDROCHLORIDE
Manufacturer
BAYSHORE PHARMACEUTICALS
Category
Drug — Prescription Medication
Hazard
Affected units
594

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 #18641
  • Exp. 05/2021

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by BAYSHORE PHARMACEUTICALS 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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